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Anatomical Chin Sizers
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref AC-SIZ-NSModel Silicone Facial Implant
Identity
- Trade Name
- Anatomical Chin Sizers FDA UDI
- Generic Name
- Chin prosthesis FDA UDI
- Device Name
- Anatomical Chin Sizers FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDAC-SIZ-NS EUDAMEDAC-SIZ FDA UDI
- Description
- Anatomical Chin Sizers FDA UDI
Identifiers
- Catalog Number
- AC-SIZ-NS FDA UDI
- Primary DI / UDI-DI
- M724ACSIZNS1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724ACSIZNS1 EUDAMED
- 510(k) Number
- K911516 FDA UDI
- FDA Product Code
- FWP FDA UDI
- EMDN Code
- P010101 CHIN PROSTHESES EUDAMED
- GMDN Term
- Chin 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: Chin prosthesis
Anatomical Chin Sizers by Implantech Associates, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Chin prosthesis.
- MEDPOR — Stryker Leibinger · Class II
- Chin Implant — Hanson Medical, Inc. · Class II
- Chin Implant — Hanson Medical, Inc. · Class II
- Chin Implant — Hanson Medical, Inc. · Class II
- Surgiform — SURGICAL TECHNOLOGY LABORATORIES INC. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
- Chin Implant — Hanson Medical, Inc. · Class II
- Spectrum Designs Medical — Spectrum Designs, Inc. · Class II
Cleared under the same submission
K911516 also covers:
- Anatomical Chin — Implantech Associates, Inc.
- Anatomical Chin — Implantech Associates, Inc.
- Anatomical Chin — Implantech Associates, Inc.
- Anatomical Chin — Implantech Associates, Inc.
- Anatomical Chin — Implantech Associates, Inc.
- Anatomical Chin — Implantech Associates, Inc.
- Anatomical Chin — Implantech Associates, Inc.
- Anatomical Chin — Implantech Associates, Inc.
- Vertical Lengthening Chin — Implantech Associates, Inc.
- Vertical Lengthening Chin — Implantech Associates, Inc.
- Vertical Lengthening Chin — Implantech Associates, Inc.
- Vertical Lengthening Chin — 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 2b4aecd0-5912-40ee-878e-7869affdf04e 36 fields · synced Jun 19, 2026
- EUDAMED 070934a7-5511-4781-b204-8ac3d48e45e7 61 fields · synced Jun 19, 2026