Identity
- Trade Name
- Combined Submalar Shell™ Sizers FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- Combined Submalar Shell™ Sizers FDA UDI
- Model / Reference
- CSM-SIZ FDA UDI
- Description
- Combined Submalar Shell™ Sizers FDA UDI
Identifiers
- Catalog Number
- CSM-SIZ-NS FDA UDI
- Primary DI / UDI-DI
- M724CSMSIZNS1 FDA UDI
- 510(k) Number
- K910655 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
Combined Submalar Shell™ Sizers by Implantech Associates, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Malar prosthesis.
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- Malar Implant — Hanson Medical, Inc. · Class II
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- 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
K910655 also covers:
- Combined Submalar Shell™ — Implantech Associates, Inc.
- Combined Submalar Shell™ — Implantech Associates, Inc.
- Combined Submalar Shell™ — Implantech Associates, Inc.
- Combined Submalar Shell™ — Implantech Associates, Inc.
- Combined Submalar Shell™ — Implantech Associates, Inc.
- Combined Submalar Shell™ — Implantech Associates, Inc.
- Combined Submalar Shell™ — Implantech Associates, Inc.
- Combined Submalar Shell™ — Implantech Associates, Inc.
- Conform Midfacial Implant Sizers — Implantech Associates, Inc.
- Conform™ Midfacial — Implantech Associates, Inc.
- Conform™ Midfacial — Implantech Associates, Inc.
- Conform™ Midfacial — 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 10ae8a69-976c-4985-a642-1e6d983e0662 36 fields · synced Jun 9, 2026