Identity
- Trade Name
- Relief ACP FDA UDI
- Generic Name
- Dental coating, tooth-desensitizing, professional FDA UDI
- Device Name
- Relief ACP Oral Care Gel, 1 Syr. Carton FDA UDI
- Model / Reference
- DIS455/02 FDA UDI
- Description
- Relief ACP Oral Care Gel, 1 Syr. Carton FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00075020034403 FDA UDI
- 510(k) Number
- K062176 FDA UDI
- FDA Product Code
- LBH FDA UDI
- GMDN Term
- Dental coating, tooth-desensitizing, professional 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
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
No
FDA UDI
Category: Dental coating, tooth-desensitizing, professional
Relief ACP by Discus Dental, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental coating, tooth-desensitizing, professional.
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Cleared under the same submission
K062176 also covers:
- Philips Relief ACP Oral Care Gel — Discus Dental, Inc.
- Philips Zoom! Chairside Light-Activated Whitening Kit — Discus Dental, Inc.
- Philips Zoom! Chairside Light-Activated Whitening Kit — Discus Dental, Inc.
- Philips Zoom! Chairside Light-Activated Whitening Kit — Discus Dental, Inc.
- Philips Zoom! Relief ACP Oral Care Gel — Discus Dental, Inc.
- Relief ACP — Discus Dental, Inc.
- Relief ACP — Discus 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Discus Dental, Inc.
Sources (1)
- FDA UDI c5b2ee72-ed27-4f28-8fcf-77d3e2851443 34 fields · synced May 30, 2026