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Conform Binder Submalar®
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref CBSM-LModel Silicone Facial Implant
Identity
- Trade Name
- Conform Binder Submalar® FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- Submalar Implant FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDCBSM-L EUDAMEDSize: Large FDA UDI
- Description
- Submalar Implant FDA UDI
Identifiers
- Catalog Number
- CBSM-L FDA UDI
- Primary DI / UDI-DI
- M724CBSML1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724CBSML1 EUDAMED
- 510(k) Number
- K973502 FDA UDI
- FDA Product Code
- LZK FDA UDI
- EMDN Code
- P010102 ZYGOMATIC PROSTHESES EUDAMED
- GMDN Term
- Malar prosthesis FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.3550 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Malar prosthesis
Conform Binder Submalar® by Implantech Associates, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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
K973502 also covers:
- Conform Binder Submalar® — Implantech Associates, Inc.
- Conform Binder Submalar® — Implantech Associates, Inc.
- Conform Binder Submalar® — Implantech Associates, Inc.
- Conform Binder Submalar® — Implantech Associates, Inc.
- Conform Binder Submalar® — Implantech Associates, Inc.
- Conform Binder Submalar® — Implantech Associates, Inc.
- Conform Binder Submalar® — Implantech Associates, Inc.
- Conform Binder Submalar® Sizers — Implantech Associates, Inc.
- Gilmore Malar — Implantech Associates, Inc.
- Gilmore Malar — Implantech Associates, Inc.
- Gilmore Malar — Implantech Associates, Inc.
- Gilmore Malar — Implantech Associates, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (2)
- FDA UDI b070f018-0a13-434e-91c9-8df32bb6f60e 36 fields · synced Jun 18, 2026
- EUDAMED c4e7dc5d-3ffd-4a1f-a643-f963337962a1 61 fields · synced Jun 18, 2026