Identity
- Trade Name
- Dentek FDA UDI
- Generic Name
- Orthodontic appliance relief material FDA UDI
- Device Name
- DNTK CANKER RELIEF 6CT PATCH 24 FDA UDI
- Model / Reference
- 00038904806A FDA UDI
- Description
- DNTK CANKER RELIEF 6CT PATCH 24 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00047701001202 FDA UDI
- FDA Product Code
- OLR FDA UDI
- GMDN Term
- Orthodontic appliance relief material FDA UDI
Classification
- Device Class
- U 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
Yes
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
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Orthodontic appliance relief material
Dentek by DenTek Oral Care, Inc. — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Orthodontic appliance relief material.
- Utility Wax — Ortho Organizers, Inc. · Class I
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- Ortho Organizers — Ortho Organizers, Inc. · Class I
- ReliaWax — RELIANCE ORTHODONTIC PRODUCTS, INC. · Class I
- Gishy Goo — ULTRADENT PRODUCTS, INC. · Class I
- PATIENT RELIEF WAX — Ortho Organizers, Inc. · Class I
- JMU — JMU DENTAL, INC · Class I
- Ortho Pro — Ortho Pro Dent LLC · Class I
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
- DenTek Oral Care, Inc.
Sources (1)
- FDA UDI 817aa1a0-e895-48db-aab8-040d17e9a5d6 34 fields · synced Jun 1, 2026