Identity
- Trade Name
- GingiTrac FDA UDI
- Generic Name
- Gingival retraction cord, non-medicated FDA UDI
- Device Name
- GingiTrac 50ml retraction paste cartridge, 2 FDA UDI
- Model / Reference
- 360100 FDA UDI
- Description
- GingiTrac 50ml retraction paste cartridge, 2 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00817051021249 FDA UDI
- 510(k) Number
- K952728 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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Gingival retraction cord, non-medicated
GingiTrac by Centrix, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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
K952728 also covers:
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Centrix, Inc.
Sources (1)
- FDA UDI fb79ac92-3eba-489f-bb75-726ccf513c34 34 fields · synced May 30, 2026