Identity
- Trade Name
- SEPARATING ABRASIVE STRIPS FDA UDI
- Generic Name
- Dental abrasive strip, single-use FDA UDI
- Device Name
- 6mm SEPARATING ABRASIVE STRIPS - MEDIUM DOUBLE-SIDED FDA UDI
- Model / Reference
- 106-224D FDA UDI
- Description
- 6mm SEPARATING ABRASIVE STRIPS - MEDIUM DOUBLE-SIDED FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00190707041427 FDA UDI
- FDA Product Code
- EHM FDA UDI
- GMDN Term
- Dental abrasive strip, single-use FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6010 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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental abrasive strip, single-use
Separating Abrasive Strips by Ortho Organizers, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental abrasive strip, single-use.
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- STEEL ABRASIVE STRIPS, 6 mm, double side coated, medium grits — Produits dentaires S.A. · Class I
- Horico — Hopf, Ringleb & Co. GmbH & Cie. · Class I
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- Horico — Hopf, Ringleb & Co. GmbH & Cie. · Class I
- ContacEZ — Directa AB · 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
- Ortho Organizers, Inc.
Sources (1)
- FDA UDI 04df96f5-5fa2-46df-9985-196c54854257 33 fields · synced Jun 9, 2026