Identity
- Trade Name
- Palodent® Plus Sectional Matrix System FDA UDI
- Generic Name
- Dental matrix band tensioner FDA UDI
- Device Name
- Palodent Plus Narrow Ring Refill FDA UDI
- Model / Reference
- 659770 FDA UDI
- Description
- Palodent Plus Narrow Ring Refill FDA UDI
Identifiers
- Catalog Number
- 659770 FDA UDI
- Primary DI / UDI-DI
- D0026597701 FDA UDI
- FDA Product Code
- DZN FDA UDI
- GMDN Term
- Dental matrix band tensioner FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.4565 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental matrix band tensioner
Palodent® Plus Sectional Matrix System by Dentsply International — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Dental matrix band tensioner.
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- Hahnenkratt — E. Hahnenkratt GmbH · Class I
- STOMA® — Storz am Mark GmbH · Class I
- HELMUT ZEPF — Helmut Zepf Medizintechnik GmbH · Class I
- STOMA® — Storz am Mark GmbH · 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
- Dentsply International
Sources (1)
- FDA UDI 29ef20f6-db83-423a-ae13-0a4a1e64a40b 37 fields · synced May 30, 2026