Identity
- Trade Name
- Perflex Thermofix FDA UDI
- Generic Name
- Composite dental impression material FDA UDI
- Device Name
- Thermoplastic pellets softens with a dip hot water to a pliable putty for immediate impression ,individual trays,bite registrations,night guards,extending walls,functional impressions,,jig in implants. Colour White 1kg net in jar FDA UDI
- Model / Reference
- White FDA UDI
- Description
- Thermoplastic pellets softens with a dip hot water to a pliable putty for immediate impression ,individual trays,bite registrations,night guards,extending walls,functional impressions,,jig in implants. Colour White 1kg net in jar FDA UDI
Identifiers
- Catalog Number
- 455001 FDA UDI
- Primary DI / UDI-DI
- 07290110501938 FDA UDI
- FDA Product Code
- EBH FDA UDI
- GMDN Term
- Composite dental impression material FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3670 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
Yes
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
Perflex Thermofix by Perflex — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Composite dental impression material.
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- 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 I | Pending data |
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Manufacturer
- Manufacturer
- Perflex
Sources (1)
- FDA UDI c557a890-54a5-4018-ba4a-b39183907e26 35 fields · synced May 30, 2026