Identity
- Trade Name
- NAVICORE PINK GUTTA PERCHA OBTURATORS 5+1/pk # 35 FDA UDI
- Generic Name
- Warm-bonded endodontic obturation system obturator FDA UDI
- Device Name
- GUTTA PERCHA OBTURATORS (6/pack) Contains: 5 obturators, 1 size verifier, Size: 35; For more information: https://www.scottsdental.com/catalog/product/view/id/31554/s/navicore-obturators/ FDA UDI
- Model / Reference
- 130-4035 FDA UDI
- Description
- GUTTA PERCHA OBTURATORS (6/pack) Contains: 5 obturators, 1 size verifier, Size: 35; For more information: https://www.scottsdental.com/catalog/product/view/id/31554/s/navicore-obturators/ FDA UDI
Identifiers
- Catalog Number
- 130-4035 FDA UDI
- Primary DI / UDI-DI
- D77813040351 FDA UDI
- FDA Product Code
- EKM FDA UDI
- GMDN Term
- Warm-bonded endodontic obturation system obturator 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
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
Category: Warm-bonded endodontic obturation system obturator
NAVICORE PINK GUTTA PERCHA OBTURATORS 5+1/pk # 35 by Scott's Dental Supply L.l.c. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Warm-bonded endodontic obturation system obturator.
- EdgeCore for EdgeCoil — US Endodontics, LLC · Class I
- EdgeCore for EdgeSequel Sapphire — US Endodontics, LLC · Class I
- Henry Schein — HENRY SCHEIN, INC. · Class I
- EdgeVerify — US Endodontics, LLC · Class I
- EdgeCore for EdgeCoil — US Endodontics, LLC · Class I
- EdgeCore for EdgeTaper — US Endodontics, LLC · Class I
- EdgeCore 20 Pack — US Endodontics, LLC · Class I
- EdgeCore for EdgeCoil — US Endodontics, LLC · 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Scott's Dental Supply L.l.c.
Sources (1)
- FDA UDI bfee4982-09e5-485e-aace-14598d7e9d4e 35 fields · synced May 30, 2026