Identity
- Trade Name
- Go-CHx Gel - 0.8% Chlorhexidine FDA UDI
- Generic Name
- Dental cavity varnish FDA UDI
- Device Name
- Go-CHx Gel is a syringeable thin, non-alcohol based gel containing 0.8% Chlorhexidine in a water soluble formula. Because of its water solubility, and low viscosity, when applied to dental restorations, it acts as a cleansing agent and does not affect bond strengths. This gel is provided in easy to use syringes with flock tips to precisely deliver the gel to the intended areas. External cleaning solution. Go-CHx Gel is recommended for use on dental restorations, prior to insertion. After applying Go-CHx Gel to cleanse the restoration, the surface of the restoration should be rinsed thoroughly with water, and then air dried prior to insertion. FDA UDI
- Model / Reference
- 0.6 mL Syr - 1ea - Evaluator FDA UDI
- Description
- Go-CHx Gel is a syringeable thin, non-alcohol based gel containing 0.8% Chlorhexidine in a water soluble formula. Because of its water solubility, and low viscosity, when applied to dental restorations, it acts as a cleansing agent and does not affect bond strengths. This gel is provided in easy to use syringes with flock tips to precisely deliver the gel to the intended areas. External cleaning solution. Go-CHx Gel is recommended for use on dental restorations, prior to insertion. After applying Go-CHx Gel to cleanse the restoration, the surface of the restoration should be rinsed thoroughly with water, and then air dried prior to insertion. FDA UDI
Identifiers
- Catalog Number
- 48-5000 FDA UDI
- Primary DI / UDI-DI
- D8374850000 FDA UDI
- 510(k) Number
- K152322 FDA UDI
- FDA Product Code
- PME FDA UDI
- GMDN Term
- Dental cavity varnish FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3260 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
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
Dimensions & Sizes
- Size
- Total Volume — 0.6 Milliliter FDA UDI
Category: Dental cavity varnish
Go-CHx Gel - 0.8% Chlorhexidine by Taub Products — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental cavity varnish.
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- NUPRO® — Dentsply Professional · Class II
Cleared under the same submission
K152322 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 II | Pending data |
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Manufacturer
- Manufacturer
- Taub Products
Sources (1)
- FDA UDI 8b6b0270-6e87-43f4-b96f-869ac9989c23 38 fields · synced May 30, 2026