Restore Implant System RS3810KRecalls & reported problems
Keystone Dental, Inc. · Implant · Class 2 · Implant
All models of Restore Implant System (21)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Keystone Restore dental implant is placed in the jaw to hold replacement teeth. Reports mostly describe implants that did not bond with the bone or came loose later, with a few mentioning the implant breaking. There are 25 reports, with 25 injuries and no deaths. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 25
- Deaths reported
- 0
- Injuries reported
- 25
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 25 adverse event reports that list this exact device (DI D768RS3810K0), received between Nov 20, 2019 and Feb 19, 2025 — classified as 25 injuries.
The most frequently reported specific device problem is “Failure to Osseointegrate” (13 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, 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.
Reports received per month
Most reported problems
Device problems
- Failure to Osseointegrate13
- Loss of Osseointegration7
- Fracture5
Patient problems
- Failure of Implant16
- Inadequate Osseointegration2
- Osteopenia/ Osteoporosis2
- Unspecified Infection2
- Bone Fracture(s)1
- No Clinical Signs, Symptoms or Conditions1
- Pain1
- Tooth Fracture1
Recent adverse event reports
The 25 most recent of 25 reports, in the reporter's own words as published by the FDA.
InjuryFeb 19, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryJan 16, 2025Loss of Osseointegration; Loss of Osseointegration
InjuryMay 9, 2023Fracture; Fracture
InjuryMay 3, 2023Fracture; Fracture
InjuryFeb 9, 2023Fracture; Fracture
InjuryApr 15, 2022Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 4, 2022Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 16, 2021Fracture; Fracture
InjuryJan 7, 2021Fracture; Fracture
InjuryJan 7, 2021Loss of Osseointegration; Loss of Osseointegration
InjuryNov 30, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryNov 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 30, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 14, 2020Loss of Osseointegration; Loss of Osseointegration
InjuryFeb 5, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 5, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryFeb 3, 2020Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 20, 2019Failure to Osseointegrate; Failure to Osseointegrate
InjuryNov 20, 2019Loss of Osseointegration; Loss of Osseointegration
Other IMPLANT, ENDOSSEOUS, ROOT-FORM devices
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM43,616 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM40,404 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM27,400 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,621 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLA Titanium BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM25,298 reports
- Straumann® Dental Implant System Roxolid® SLA Impl. SLA Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM23,448 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,320 reports
- STRAUMANN BONE LEVEL TAPERED IMPLANT SLActive Roxolid BLInstitut Straumann AG · IMPLANT, ENDOSSEOUS, ROOT-FORM22,267 reports
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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