Philips Zoom! Chairside Light-Activated Whitening Kit DIS556Recalls & reported problems
Discus Dental, LLC · Zoom! Tooth Whitening Procedure Kit (25% HP), with NiteWhite 22% CP & Relief ACP Oral Care Gel · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 8
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 00075020034991), received between Jul 21, 2017 and Jul 20, 2023 — classified as 8 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).
1 other recall cover devices cleared under the same FDA submission (K062176); they may or may not involve this specific model.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem7
- Improper or Incorrect Procedure or Method1
- Off-Label Use1
Patient problems
- Reaction4
- Burn(s)2
- Patient Problem/Medical Problem1
- Sensitivity of Teeth1
- Swelling1
Recent adverse event reports
The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.
InjuryJul 20, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
ON JULY 6, 2023, NEW INFORMATION WAS RECEIVED. IT WAS REPORTED THE PATIENT WAS DIAGNOSED WITH VOCAL FOLD TRAUMA THAT OCCURRED IN (B)(6) 2022. THE PATIENT PRESENTED WITH BILATERAL TRUE VOCAL FOLD HEMORRHAGES WITH ACUTE LOSS OF VOICE AND VOCAL FOLD VIBRATION. THIS APPEARANCE OF THE VOCAL HEMORRHAGES SUGGESTED ACUTE TRAUMA TO THE LINING OF THE VOCAL FOLDS.
Patient problems: Burn(s)
MAUDE report 17367612 ↗InjuryMar 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2020 IN WHICH A PATIENT WHO DID THE WHITENING ON FRIDAY (B)(6) 2020 AND AFTER THE WHITENING, HE EXPERIENCED CERTAIN EFFECTS LIKE CHILL, SHAKING AND FATIGUE. THE FOLLOWING DAY, THESE SYMPTOMS WERE GONE. HOWEVER, STARTED TO HAVE HERPES ALL OVER HIS LIP. THE PATIENT SOUGHT MEDICAL ATTENTION AND WAS PRESCRIBED MEDICATION.
Patient problems: Patient Problem/Medical Problem
MAUDE report 9795841 ↗InjurySep 21, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(4) 2018, IN WHICH THE PATIENTS FACE BEGAN TO SWELL AFTER A ZOOM CHAIRSIDE WHITENING PROCEDURE. THE PATIENT ALSO DEVELOPED NUMBNESS AND SWELLING OF HER LOWER LIP. THE PATIENT WENT TO URGENT CARE AND WAS GIVEN DEXAMETHASONE INJECTION, 3 DOSES OF BENADRYL AND WAS PRESCRIBED 20MLG PREDNISONE.
Patient problems: Reaction
MAUDE report 7900055 ↗InjuryJun 20, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISCUS DENTAL RECEIVED A COMPLAINT ON 05/24/2018, IN WHICH DENTAL ASSISTANT REPORTED THAT IN OFFICE TEETH WHITENING GEL DRIPPED ONTO PATIENT'S MANDIBLE. PATIENT EXPERIENCED SWOLLEN WHITE/GREY CERVICAL MARGINS. DENTIST RECOMMENDED MAGIC MOUTHWASH, PEROXYL AND CANKER SORE OTC DRUG. PATIENT IS DOING BETTER, PATIENT CONTINUES TO USE VITAMIN E OIL AND MAGIC MOUTHWASH.
Patient problems: Burn(s)
MAUDE report 7623659 ↗InjuryJun 8, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2018 IN WHICH PATIENT HAD AN ALLERGIC REACTION 3 DAYS AFTER IN-OFFICE TEETH WHITENING PROCEDURE STATING THAT SHE HAD A RASH ON THE OUTSIDE RIM OF BOTH LIPS. PATIENT SAW PHYSICIAN AFTER THE REACTION.
Patient problems: Reaction
MAUDE report 7583736 ↗InjuryMay 25, 2018Off-Label Use; Adverse Event Without Identified Device or Use Problem; Off-Label Use; Adverse Event Without Identified Device or Use Problem
DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2018 IN WHICH PATIENT EXPERIENCED SWOLLEN LIPS AFTER IN-OFFICE ZOOM TEETH WHITENING PROCEDURE. DENTIST STATED THAT HE USED A WINGED RETRACTOR AND NOT THE RETRACTOR PROVIDED WITH THE ZOOM CHAIRSIDE KIT. PATIENT HAS BEEN ICING LIP AND TOOK BENADRYL. DENTIST STATED THAT THE PATIENT VISITED A PHYSICIAN AND RECEIVED MEDICATION, HOWEVER, THE PATIENT DID NOT DISCLOSE THE TYPE OF MEDICATION.
Patient problems: Swelling
MAUDE report 7546497 ↗InjuryOct 4, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISCUS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017 IN WHICH PATIENT HAD AN ALLERGIC REACTION AND BROKE OUT IN HIVES DURING IN-OFFICE TEETH WHITENING PROCEDURE. NO PAIN OR INJURY IN THE MOUTH OR LIPS WAS REPORTED. THE PATIENT TOOK BENADRYL AND WAS REFERRED TO SEE AN ALLERGIST BY HER DENTIST. NO INFORMATION WAS PROVIDED IF THE PATIENT VISITED A SPECIALIST OR NOT. THE DENTIST MENTIONED THAT THE PATIENT APPEARED ITCHY AND UNCOMFORTABLE BEFORE STARTING THE PROCEDURE. THE HIVES WERE CLEARED UP WITHIN THE NEXT DAY.
Patient problems: Reaction
MAUDE report 6914176 ↗InjuryJul 21, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISCUSS DENTAL RECEIVED A COMPLAINT ON (B)(6) 2017, IN WHICH PATIENT INITIALLY EXPERIENCED PAIN DURING ZOOM IN-OFFICE TEETH WHITENING PROCEDURE. TEN MINUTES LATER, HIVES APPEARED ON PATIENT'S FACE, BACK AND ARMS. STEROIDS WERE PRESCRIBED BY THE MEDICAL DOCTOR. THE PATIENT WAS FEELING BETTER 2 DAYS AFTER THE EVENT, AND WAS HEALED ONE WEEK AFTER THE INCIDENT.
Patient problems: Reaction; Sensitivity of Teeth
MAUDE report 6734079 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K062176. One submission often covers many models, so check the product and lot details in each record.
- Z-0425-2015 · Oct 24, 2014 · TerminatedRelief ACP Oral Care Gel intended to relieve discomfort from dentin sensitivity. Sold separately in single, single syringe, 4 packs, 6 packs and in teeth whitening kits
Other VARNISH, CAVITY devices
- Fast Release Varnish 12158M3m Company · VARNISH, CAVITY1 recall0 reports
- IRIS 4323-635Benco Dental Supply CO. · Varnish, Cavity1 recall0 reports
- Philips Zoom! Chairside Light-Activated Whitening Kit DIS557Discus Dental, LLC · VARNISH, CAVITY7 reports
- Fast Release Varnish 12158S3m Company · VARNISH, CAVITY2 reports
- MEDICOM DURAFLOR HALO 1015-WB32 PK6AMD Medicom Inc · VARNISH, CAVITY2 reports
- Varnish Pen - Assorted 295782Young Dental Manufacturing I, LLC · Varnish, Cavity1 report
- Vanish™ 12150M3m Company · VARNISH, CAVITY1 report
- Darby Dental Supply, LLC 9430600Darby Dental Supply, LLC · VARNISH, CAVITY1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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