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First String Advanced Braided Retraction Cord Non-Impregnated - Medium
FDA UDIClass U (US FDA UDI)
Identity
- Trade Name
- First String Advanced Braided Retraction Cord Non-Impregnated - Medium FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- Gingival retraction cord, non-medicated FDA UDI
- Model / Reference
- 640109 FDA UDI
- Description
- Gingival retraction cord, non-medicated FDA UDI
Identifiers
- Catalog Number
- 640109 FDA UDI
- Primary DI / UDI-DI
- 00359883005641 FDA UDI
- 510(k) Number
- K981596 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction cord, non-medicated FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 244 Centimeter FDA UDI
Category: Gingival retraction cord, non-medicated
First String Advanced Braided Retraction Cord Non-Impregnated - Medium by Den-Mat Holdings, LLC — Class U — FDA UDI — listed in FDA GUDID
Similar devices
Also classified as Gingival retraction cord, non-medicated.
- R-101 — PASCAL COMPANY, INC. · Class I
- Smartcord 2 — EASTDENT Co., Ltd · Class I
- roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- Hilo de retracción tejido Nº2 Dentaflux — J RIPOLL SL · Class I
- Hilo de retracción tejido Nº00 Dentaflux — J RIPOLL SL · Class I
- Henry Schein — HENRY SCHEIN, INC. · U
- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
Cleared under the same submission
K981596 also covers:
- A. Titan Instruments — A.Titan Instruments
- A. Titan Instruments — A.Titan Instruments
- A. Titan Instruments — A.Titan Instruments
- First String Advanced Braided Retraction Cord Non-Impregnated - Extra Small — Den-Mat Holdings, LLC
- First String Advanced Braided Retraction Cord Non-Impregnated - Large — Den-Mat Holdings, LLC
- First String Advanced Braided Retraction Cord Non-Impregnated - Small — Den-Mat Holdings, LLC
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, INC.
- Patterson® — PATTERSON DENTAL SUPPLY, 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 U | Pending data |
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Manufacturer
- Manufacturer
- Den-Mat Holdings, LLC
Sources (1)
- FDA UDI 7c8db86c-f2ea-44a8-abb2-a44d10d39d6d 38 fields · synced Jun 9, 2026