Identity
- Trade Name
- AccuFilm® FDA UDI
- Generic Name
- Dental articulation paper FDA UDI
- Device Name
- Red AccuFilm® I Single-Sided for Korea FDA UDI
- Model / Reference
- S015-K FDA UDI
- Description
- Red AccuFilm® I Single-Sided for Korea FDA UDI
Identifiers
- Catalog Number
- S015-K FDA UDI
- Primary DI / UDI-DI
- 10810000526168 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental articulation paper
AccuFilm® by Parkell, Inc. — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental articulation paper.
- Articulating paper/film — WHIP-MIX CORP. · Class I
- Touch-free T-Scan Evolution Supports (Box) — Tekscan, Inc. · 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Parkell, Inc.
Sources (2)
- FDA UDI 4acdc58c-1a7e-4a8d-9789-b3b79e8bb014 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced May 29, 2026