Restore Implant SystemRecalls & reported problems across all models
Keystone Dental, Inc. · 21 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 131
- Deaths reported
- 0
- Injuries reported
- 131
- Recalls
- 0
We found 21 models of Restore Implant System by Keystone Dental, Inc. in the FDA's device registry (GUDID). Together they are named in 131 adverse event reports in the FDA's MAUDE database, received between Nov 20, 2019 and Aug 5, 2025 — classified as 131 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (69 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Restore Implant System problems
Device problems
- Failure to Osseointegrate69
- Loss of Osseointegration54
- Fracture10
Patient problems
- Failure of Implant55
- Inadequate Osseointegration51
- Osteopenia/ Osteoporosis19
- Unspecified Infection13
- Bruxism9
- High Blood Pressure/ Hypertension5
- Pain5
- Implant Pain4
Restore Implant System models
21 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Restore Implant System RS3810KIMPLANT, ENDOSSEOUS, ROOT-FORM25 reports
- Restore Implant System RS3811KIMPLANT, ENDOSSEOUS, ROOT-FORM14 reports
- Restore Implant System RS3813KIMPLANT, ENDOSSEOUS, ROOT-FORM13 reports
- Restore Implant System RS4013KIMPLANT, ENDOSSEOUS, ROOT-FORM12 reports
- Restore Implant System RS4010KIMPLANT, ENDOSSEOUS, ROOT-FORM9 reports
- Restore Implant System RS3808KIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Restore Implant System RS4008KIMPLANT, ENDOSSEOUS, ROOT-FORM7 reports
- Restore Implant System RS5010KIMPLANT, ENDOSSEOUS, ROOT-FORM6 reports
- Restore Implant System RS4011KIMPLANT, ENDOSSEOUS, ROOT-FORM5 reports
- Restore Implant System RS3311KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Restore Implant System RS3315KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Restore Implant System RS6008KIMPLANT, ENDOSSEOUS, ROOT-FORM4 reports
- Restore Implant System RS3310KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Restore Implant System RS3815KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Restore Implant System RS6013KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Restore Implant System RS6015KIMPLANT, ENDOSSEOUS, ROOT-FORM3 reports
- Restore Implant System RS3308KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Restore Implant System RS5008KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Restore Implant System RS5011KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Restore Implant System RS5015KIMPLANT, ENDOSSEOUS, ROOT-FORM2 reports
- Restore Implant System RS4015KIMPLANT, ENDOSSEOUS, ROOT-FORM1 report
Recent Restore Implant System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryAug 5, 2025Failure to Osseointegrate; Failure to Osseointegrate
InjuryJun 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Implant Pain; Inadequate Osseointegration
MAUDE report 22338052 ↗InjuryJun 26, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 22337993 ↗InjuryApr 18, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Inadequate Osseointegration; Osteopenia/ Osteoporosis
MAUDE report 21867918 ↗InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 27, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMar 25, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 20, 2025Loss of Osseointegration; Loss of Osseointegration
LOSS OF OSSEOINTEGRATION.
Patient problems: Bruxism; Inadequate Osseointegration
MAUDE report 21190558 ↗
Other Keystone Dental, Inc. products
All Keystone Dental, Inc. devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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