Identity
- Trade Name
- AxioSil Heavy Body FDA UDI
- Generic Name
- Composite dental impression material FDA UDI
- Model / Reference
- 26015 2 x 50ml Fast Set FDA UDI
Identifiers
- Primary DI / UDI-DI
- D161260150 FDA UDI
- FDA Product Code
- ELW FDA UDI
- GMDN Term
- Composite dental impression material FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3660 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
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: Composite dental impression material
Get precise, accurate impressions of your patient's oral anatomy with the AxioSil Heavy Body dental impression material. This single-use, thermoplastic composite material is designed for use in both temporary and definitive dental restorations, providing unparalleled detail and precision.
Similar devices
Also classified as Composite dental impression material.
- Accusil Heavy Body — PREVEST DENPRO LIMITED · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Bosworth Sapphire — Harry J. Bosworth Co. · Class II
- UltraSil Putty 1000 — Dsi Dental Solutions, Ltd. · Class II
- Accusil Monophase — PREVEST DENPRO LIMITED · Class II
- Patterson® — PATTERSON DENTAL SUPPLY, INC. · Class II
- Bosworth Superbite — Harry J. Bosworth Co. · Class II
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
- Axiodent Inc.
Sources (1)
- FDA UDI a25611bf-0117-4ee6-b52b-3776974263f9 32 fields · synced Jun 21, 2026