Identity
- Trade Name
- Roydent Gutta Percha FDA UDI
- Generic Name
- Synthetic gutta-percha FDA UDI
- Device Name
- Gutta Percha Points Size Size: 25 .04 Taper FDA UDI
- Model / Reference
- 504025R FDA UDI
- Description
- Gutta Percha Points Size Size: 25 .04 Taper FDA UDI
Identifiers
- Catalog Number
- 504025R FDA UDI
- Primary DI / UDI-DI
- D809504025R1 FDA UDI
- FDA Product Code
- EKM FDA UDI
- GMDN Term
- Synthetic gutta-percha FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.3850 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
Yes
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
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Liquid Chemical FDA UDI
Category: Synthetic gutta-percha
Roydent Gutta Percha by Roydent Dental Products Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic gutta-percha.
- Vortex Blue Conform Fit — TULSA DENTAL PRODUCTS LLC · Class I
- MX 06-20 — Meta Biomed, Inc. · Class I
- Safco gutta percha points — Safco Dental Supply · Class I
- Vortex Blue Conform Fit — TULSA DENTAL PRODUCTS LLC · Class I
- EdgeSequel™ — US Endodontics, LLC · Class I
- Gutta Percha Points — TULSA DENTAL PRODUCTS LLC · Class I
- Gutta Percha 02-80 — Meta Biomed, Inc. · Class I
- Gutta Percha 04-45 — Meta Biomed, 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
- Roydent Dental Products Inc
Sources (1)
- FDA UDI 032ac1c3-dd47-4d4e-a889-c119cd7743b1 34 fields · synced Jun 7, 2026