Identity
- Trade Name
- Terino Malar Shell® FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- Malar Implant FDA UDI
- Model / Reference
- Size: Medium (4mm) FDA UDI
- Description
- Malar Implant FDA UDI
Identifiers
- Catalog Number
- TMS-M4-NS FDA UDI
- Primary DI / UDI-DI
- M724TMSM4NS1 FDA UDI
- 510(k) Number
- K901662 FDA UDI
- FDA Product Code
- LZK FDA UDI
- GMDN Term
- Malar prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Malar prosthesis
Terino Malar Shell® by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Malar prosthesis.
- Malar Implant — Hanson Medical, Inc. · Class II
- Malar Implant — Hanson Medical, Inc. · Class II
- Malar Implant — Hanson Medical, Inc. · Class II
- Malar Implant — Hanson Medical, Inc. · Class II
- Surgiform — SURGICAL TECHNOLOGY LABORATORIES INC. · Class II
- Malar Implant — Hanson Medical, Inc. · Class II
- Dental Gracey Currettes — Burhan Kamran Industries · Class I
- Malar Implant — Hanson Medical, Inc. · Class II
Cleared under the same submission
K901662 also covers:
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Conform Terino Malar Shell® — Implantech Associates, Inc.
- Terino Malar Shell® — Implantech Associates, Inc.
- Terino Malar Shell® — Implantech Associates, Inc.
- Terino Malar Shell® — Implantech Associates, 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
- Implantech Associates, Inc.
Sources (1)
- FDA UDI 3908c9cd-79aa-4e53-9fa5-a093ce1ab07a 36 fields · synced Jun 9, 2026