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Binder Submalar® II Sizer
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref BSMII-SIZ-NSModel Silicone Facial Implant
Identity
- Trade Name
- Binder Submalar® II Sizer FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- Binder Submalar® II Sizer FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDBSMII-SIZ-NS EUDAMEDBSMII-SIZ FDA UDI
- Description
- Binder Submalar® II Sizer FDA UDI
Identifiers
- Catalog Number
- BSMII-SIZ-NS FDA UDI
- Primary DI / UDI-DI
- M724BSMIISIZNS1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724BSMIISIZNS1 EUDAMED
- 510(k) Number
- K895152 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
No
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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Malar prosthesis
Binder Submalar® II Sizer 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
K895152 also covers:
- Binder Submalar® II — Implantech Associates, Inc.
- Binder Submalar® II — Implantech Associates, Inc.
- Binder Submalar® II — Implantech Associates, Inc.
- Binder Submalar® II — Implantech Associates, Inc.
- Binder Submalar® II — Implantech Associates, Inc.
- Binder Submalar® II — Implantech Associates, Inc.
- Binder Submalar® II — Implantech Associates, Inc.
- Binder Submalar® II — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Implantech Associates, Inc.
Sources (2)
- FDA UDI a7842706-029a-48e4-b366-fd6574b7aa69 36 fields · synced Jul 16, 2026
- EUDAMED 93471ab7-e2a5-4d4d-a1ec-8b21f4a25221 61 fields · synced Jul 16, 2026