Temporal Shell Implant Sizers
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Temporal Shell Implant Sizers FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Temporal Shell Implant Sizers FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDTS-SIZ-NS EUDAMEDTS-SIZ FDA UDI
- Description
- Temporal Shell Implant Sizers FDA UDI
Identifiers
- Catalog Number
- TS-SIZ-NS FDA UDI
- Primary DI / UDI-DI
- M724TSSIZNS1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724TSSIZNS1 EUDAMED
- 510(k) Number
- K943644 FDA UDI
- FDA Product Code
- FWP FDA UDI
- EMDN Code
- P010102 ZYGOMATIC PROSTHESES EUDAMED
- GMDN Term
- Silicone-block tissue reconstructive material 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
Single Use
Yes
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
No
Manufacturing Date
Yes
Category: Silicone-block tissue reconstructive material
Temporal Shell Implant Sizers by Implantech Associates, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Silicone-block tissue reconstructive material.
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Cleared under the same submission
K943644 also covers:
- Extended Temporal Shell™ Implant — Implantech Associates, Inc.
- Extended Temporal Shell™ Implant — Implantech Associates, Inc.
- Extended Temporal Shell™ Implant — Implantech Associates, Inc.
- Extended Temporal Shell™ Implant — Implantech Associates, Inc.
- Extended Temporal Shell™ Implant — Implantech Associates, Inc.
- Extended Temporal Shell™ Implant — Implantech Associates, Inc.
- Extended Temporal Shell™ Implant — Implantech Associates, Inc.
- Extended Temporal Shell™ Implant — Implantech Associates, Inc.
- Temporal Shell Implant — Implantech Associates, Inc.
- Temporal Shell Implant — Implantech Associates, Inc.
- Temporal Shell Implant — Implantech Associates, Inc.
- Temporal Shell Implant — Implantech Associates, Inc.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
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 6d0d6e3d-c56d-4d2a-8bd9-59632ecafd23 36 fields · synced Jul 9, 2026
- EUDAMED 0762ea0c-b331-4404-b148-719fe93ddf52 61 fields · synced Jul 9, 2026