Identity
- Trade Name
- Maarc dental - Articulating Paper FDA UDI
- Generic Name
- Dental articulation paper FDA UDI
- Device Name
- A diagnostic tool used in dentistry to highlight occlusal contacts and the distribution of occlusal forces. That is, it marks those points on the teeth where the teeth contact during biting and grinding. FDA UDI
- Model / Reference
- 5521/001 FDA UDI
- Description
- A diagnostic tool used in dentistry to highlight occlusal contacts and the distribution of occlusal forces. That is, it marks those points on the teeth where the teeth contact during biting and grinding. FDA UDI
Identifiers
- Catalog Number
- 5521/001 FDA UDI
- Primary DI / UDI-DI
- 08906110440175 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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Safe FDA UDI
Category: Dental articulation paper
Maarc dental - Articulating Paper by Shiva Products — 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
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- 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
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
- Shiva Products
Sources (1)
- FDA UDI cbddc56b-42fa-4737-b87a-23142d25bce7 36 fields · synced May 31, 2026