Identity
- Trade Name
- T-Scan Novus Handpiece FDA UDI
- Generic Name
- Dental articulation paper FDA UDI
- Device Name
- 1 Novus Handpiece (USB Connection) FDA UDI
- Model / Reference
- T-Scan Novus FDA UDI
- Description
- 1 Novus Handpiece (USB Connection) FDA UDI
Identifiers
- Catalog Number
- DH-1 FDA UDI
- Primary DI / UDI-DI
- B970DH10 FDA UDI
- FDA Product Code
- EFH FDA UDI
- GMDN Term
- Dental articulation paper FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6140 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
No
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental articulation paper
T-Scan Novus Handpiece by Tekscan, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental articulation paper.
- AccuFilm® — PARKELL, INC. · Class I
- Articulating paper/film — WHIP-MIX CORP. · Class I
- Articulating Paper — Pulpdent Corporation · Class I
- ARDENT — WHIP-MIX CORP. · Class I
- Health-Tec/DHP Articulating Paper — Dental Health Products Inc · Class I
- Spot it — Directa AB · Class I
- Health-Tec/DHP Articulating Paper — Dental Health Products Inc · Class I
- Articulating paper/film — WHIP-MIX CORP. · 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 I | Pending data |
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Manufacturer
- Manufacturer
- Tekscan, Inc.
Sources (1)
- FDA UDI 896d5e43-93e2-4fc5-9ab2-b9822b36ceb8 34 fields · synced May 30, 2026