Identity
- Trade Name
- Restore FDA UDI
- Generic Name
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
- Device Name
- Healing Cap FDA UDI
- Model / Reference
- 42022K FDA UDI
- Description
- Healing Cap FDA UDI
Identifiers
- Catalog Number
- 42022K FDA UDI
- Primary DI / UDI-DI
- D76842022K0 FDA UDI
- 510(k) Number
- K003226 FDA UDI
- FDA Product Code
- NHA FDA UDI
- GMDN Term
- Dental implant suprastructure, temporary, preformed, single-use FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3630 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental implant suprastructure, temporary, preformed, single-use
Restore by Keystone Dental Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental implant suprastructure, temporary, preformed, single-use.
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- Retaining Screw for Digital Model Analog — ADIN DENTAL IMPLANT SYSTEMS LTD. · Class I
- Falcon — Falcon Surgical Co. (Pvt.) Ltd · Class I
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- Neoss Implant System — Neoss, Ltd. · Class II
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Cleared under the same submission
K003226 also covers:
- Restore — Keystone Dental Inc.
- Restore — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
- Stage 1 — Keystone Dental Inc.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Keystone Dental Inc.
Sources (1)
- FDA UDI 5c30f58b-0766-4139-8ebc-e7cafcf3b625 37 fields · synced May 31, 2026