Identity
- Trade Name
- Premium UNIFY Silk Sutures FDA UDI
- Generic Name
- Silk suture FDA UDI
- Device Name
- Premium UNIFY Silk Sutures, 4-0, 13mm 3/8 circle Rev Cut, 18". Black. FDA UDI
- Model / Reference
- PSS-418R13 FDA UDI
- Description
- Premium UNIFY Silk Sutures, 4-0, 13mm 3/8 circle Rev Cut, 18". Black. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00814639026771 FDA UDI
- 510(k) Number
- K161633 FDA UDI
- FDA Product Code
- GAP FDA UDI
- GMDN Term
- Silk suture FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.5030 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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Silk suture
Premium UNIFY Silk Sutures by Applied Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Silk suture.
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- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
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- Sofsilk — Covidien LP · Class II
- DemeSILK — DemeTECH Corp · Class II
- DemeSILK — DemeTECH Corp · Class II
Cleared under the same submission
K161633 also covers:
- Premium UNIFY Nylon Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Nylon Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Nylon Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Nylon Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Nylon Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Nylon Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Silk Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Silk Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Silk Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Silk Sutures — APPLIED DENTAL, INC.
- Premium UNIFY Silk Sutures — APPLIED DENTAL, 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
- Applied Dental, Inc.
Sources (1)
- FDA UDI 2dade179-a30f-4bdf-86c8-067aa9eb59b9 35 fields · synced Jun 1, 2026