← Back to catalogue
Mandibular Pre Jowl Sizers
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref MPJC-SIZ-NSModel Silicone Facial Implant
Identity
- Trade Name
- Mandibular Pre Jowl Sizers FDA UDI
- Generic Name
- Chin prosthesis FDA UDI
- Device Name
- Pre Jowl Sizers FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDMPJC-SIZ-NS EUDAMEDMPJC-SIZ FDA UDI
- Description
- Pre Jowl Sizers FDA UDI
Identifiers
- Catalog Number
- MPJC-SIZ-NS FDA UDI
- Primary DI / UDI-DI
- M724MPJCSIZNS1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724MPJCSIZNS1 EUDAMED
- 510(k) Number
- K902826 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
Mandibular Pre Jowl 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
K902826 also covers:
- Mandibular Pre Jowl Chin™ — Implantech Associates, Inc.
- Mandibular Pre Jowl Chin™ — Implantech Associates, Inc.
- Mandibular Pre Jowl Chin™ — Implantech Associates, Inc.
- Mandibular Pre Jowl Chin™ — Implantech Associates, Inc.
- Mandibular Pre Jowl Chin™ — Implantech Associates, Inc.
- Mandibular Pre Jowl Chin™ — Implantech Associates, Inc.
- Mandibular Pre Jowl Chin™ — Implantech Associates, Inc.
- Mandibular Pre Jowl 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 e177c91c-3eb8-49c6-9733-880c93927a9b 36 fields · synced Jul 22, 2026
- EUDAMED 119275dc-58e3-4b51-bb62-3294ec4164b5 61 fields · synced Jul 22, 2026