Identity
- Trade Name
- Pureform FDA UDI
- Generic Name
- Malar prosthesis FDA UDI
- Device Name
- "1ML03 PureForm - ePTFE Malar - Medium" FDA UDI
- Model / Reference
- 1ML03 FDA UDI
- Description
- "1ML03 PureForm - ePTFE Malar - Medium" FDA UDI
Identifiers
- Catalog Number
- 1ML03 FDA UDI
- Primary DI / UDI-DI
- 00850987007055 FDA UDI
- 510(k) Number
- K091011 FDA UDI
- FDA Product Code
- LZK FDA UDI
- GMDN Term
- Malar prosthesis FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.3550 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Malar prosthesis
Pureform by Surgical Technology Laboratories Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Malar prosthesis.
- Binder Submalar® — Implantech Associates, Inc. · Class II
- Conform Binder Submalar® — Implantech Associates, Inc. · Class II
- Conform™ Midfacial — Implantech Associates, Inc. · Class II
- Malar Implant — Hanson Medical, Inc. · Class II
- Conform™ Midfacial — Implantech Associates, Inc. · Class II
- Malar Implant — Hanson Medical, Inc. · Class II
- Malar Implant — Implantech Associates, Inc. · Class II
- 900-014 Profile Malar Sizer Set — Implantech Associates, Inc. · Class II
Cleared under the same submission
K091011 also covers:
- PureForm — SURGICAL TECHNOLOGY LABORATORIES INC.
- PureForm — SURGICAL TECHNOLOGY LABORATORIES INC.
- PureForm — SURGICAL TECHNOLOGY LABORATORIES INC.
- PureForm — SURGICAL TECHNOLOGY LABORATORIES INC.
- PureForm — SURGICAL TECHNOLOGY LABORATORIES INC.
- Pureform — SURGICAL TECHNOLOGY LABORATORIES INC.
- Pureform — SURGICAL TECHNOLOGY LABORATORIES INC.
- Pureform — SURGICAL TECHNOLOGY LABORATORIES INC.
- Pureform — SURGICAL TECHNOLOGY LABORATORIES INC.
- Pureform — SURGICAL TECHNOLOGY LABORATORIES INC.
- Pureform — SURGICAL TECHNOLOGY LABORATORIES INC.
- Pureform — SURGICAL TECHNOLOGY LABORATORIES INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Surgical Technology Laboratories Inc.
Sources (1)
- FDA UDI 6f23ecf5-689d-4033-935c-7c0a48684e6d 35 fields · synced May 30, 2026