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Gutta Percha 04-45
FDA UDIEUDAMEDClass I (US FDA UDI)
Ref -Model Gutta Percha 04-45
Identity
- Trade Name
- Gutta Percha Points EUDAMEDGutta Percha 04-45 FDA UDI
- Generic Name
- Synthetic gutta-percha FDA UDI
- Device Name
- Gutta Percha Points EUDAMEDGutta Percha Points and Bars 04 taper #45, 60 Points, P31R FDA UDI
- Model / Reference
- Gutta Percha 04-45 EUDAMED- EUDAMED0869 FDA UDI
- Description
- Gutta Percha Points and Bars 04 taper #45, 60 Points, P31R FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08806387808695 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08806387808695 EUDAMED
- FDA Product Code
- EKM FDA UDI
- EMDN Code
- Q01010203 DENTAL CONES EUDAMED
- GMDN Term
- Synthetic gutta-percha FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.3850 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Yes
FDA UDI
Category: Synthetic gutta-percha
Gutta Percha 04-45 by Meta Biomed, Inc. — Class I — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Synthetic gutta-percha.
- Gutta Percha Points — ROYDENT DENTAL PRODUCTS INC · Class I
- Roydent Gutta Percha — ROYDENT DENTAL PRODUCTS INC · Class I
- Vortex Blue Conform Fit — TULSA DENTAL PRODUCTS LLC · 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
- Henry Schein — HENRY SCHEIN, INC. · Class I
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Meta Biomed, Inc.
Sources (2)
- FDA UDI 67a62950-a078-4478-9f22-df80ec70c6e5 33 fields · synced Jul 8, 2026
- EUDAMED 5094aa70-7c37-4eaa-900e-065c3a69d61c 61 fields · synced Jul 8, 2026