Identity
- Trade Name
- Bioviva-3D Dental FDA UDI
- Generic Name
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
- Device Name
- Basik PGC SUTURE USP 3/0..3/8 REV CUTTING NEEDLE 24MM LENGTH One Device FDA UDI
- Model / Reference
- BPGC942 FDA UDI
- Description
- Basik PGC SUTURE USP 3/0..3/8 REV CUTTING NEEDLE 24MM LENGTH One Device FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817169021131 FDA UDI
- 510(k) Number
- K130737 FDA UDI
- FDA Product Code
- GAM FDA UDI
- GMDN Term
- Polyester suture, bioabsorbable, monofilament, non-antimicrobial FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4493 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
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Polyester suture, bioabsorbable, monofilament, non-antimicrobial
Bioviva-3D Dental by 3d Dental Designs And Development, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Polyester suture, bioabsorbable, monofilament, non-antimicrobial.
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Cleared under the same submission
K130737 also covers:
- Premium UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- Premium UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- UNIFY PGCL Surgical Sutures — APPLIED DENTAL, INC.
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
- Oasis — American Health Service Sales Corporation
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
- 3d Dental Designs And Development, Llc
Sources (1)
- FDA UDI 19e514ee-5312-4c77-b50e-8db3214b0aaf 34 fields · synced Jun 8, 2026