Rectangular Carving Block 1.0
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- Rectangular Carving Block 1.0 FDA UDI
- Generic Name
- Silicone-block tissue reconstructive material FDA UDI
- Device Name
- Rectangular Carving Block 1.0, Clear, Soft FDA UDI
- Model / Reference
- Silicone Facial Implant EUDAMEDBL1.0-OS-NS EUDAMEDSize: 13.6cm x 5.8cm x 1.0cm FDA UDI
- Description
- Rectangular Carving Block 1.0, Clear, Soft FDA UDI
Identifiers
- Catalog Number
- BL-1.0-CS FDA UDI
- Primary DI / UDI-DI
- M724BL10CSNS1 EUDAMEDFDA UDI
- Basic UDI-DI
- B-M724BL10CSNS1 EUDAMED
- 510(k) Number
- K952706 FDA UDI
- FDA Product Code
- MIB FDA UDI
- EMDN Code
- P010199 FACIAL PROSTHESES - OTHER EUDAMED
- GMDN Term
- Silicone-block tissue reconstructive material FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3620 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
Rectangular Carving Block 1.0 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
K952706 also covers:
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block — Implantech Associates, Inc.
- Contoured Carving Block Sizer — Implantech Associates, Inc.
- Contoured Carving Block Sizer — Implantech Associates, Inc.
- Contoured Carving Block Sizer — 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 70c11720-6a44-4c3d-9726-e4042ce93551 36 fields · synced Jul 8, 2026
- EUDAMED 191a53df-3ba1-45dd-9a13-87aa16b15103 61 fields · synced Jun 18, 2026