Identity
- Trade Name
- Traxodent - Itena FDA UDI
- Generic Name
- Gingival retraction solution FDA UDI
- Device Name
- Traxodent Trial (2 pack) - ITENA FDA UDI
- Model / Reference
- TRASTRT-2 FDA UDI
- Description
- Traxodent Trial (2 pack) - ITENA FDA UDI
Identifiers
- Catalog Number
- 7007097 FDA UDI
- Primary DI / UDI-DI
- 00348783001020 FDA UDI
- 510(k) Number
- K083695 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction solution 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 solution
Traxodent - Itena by Premier Dental Products Company — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K083695 also covers:
- Traxodent — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent - Itena — PREMIER DENTAL PRODUCTS COMPANY
- Traxodent - Itena — PREMIER DENTAL PRODUCTS COMPANY
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
- Premier Dental Products Company
Sources (1)
- FDA UDI 410b83a2-a138-420c-82d6-996fb9e36d9d 35 fields · synced Jun 1, 2026