← Back to catalogue

Therma-Kor

FDA UDI

Class I (US FDA UDI)

by Xlent Global Inc

Identity

Trade Name
Therma-Kor FDA UDI
Generic Name
Warm-bonded endodontic obturation system obturator FDA UDI
Device Name
Therma-Kor Endo Obturator 25mm #45 (6/PK) FDA UDI
Model / Reference
TK-46062545 FDA UDI
Description
Therma-Kor Endo Obturator 25mm #45 (6/PK) FDA UDI

Identifiers

Catalog Number
TK-46062545 FDA UDI
Primary DI / UDI-DI
00810135270069 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

Yes

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

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Warm-bonded endodontic obturation system obturator

Therma-Kor by Xlent Global Inc — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Warm-bonded endodontic obturation system obturator.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Xlent Global Inc

Sources (1)

  • FDA UDI 9ff853ab-ae39-4d70-b98d-b04e65979a0e 34 fields · synced May 30, 2026