Hot Testing Tip

GUDID 08800019100577

B& L Biotech, inc.

Endodontic obturation system
Primary Device ID08800019100577
NIH Device Record Key7c360659-5c6c-440f-aec7-8e8dfea47615
Commercial Distribution StatusIn Commercial Distribution
Brand NameHot Testing Tip
Version Model NumberHHTT
Company DUNS687338285
Company NameB& L Biotech, inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800019100577 [Primary]

FDA Product Code

EKRPlugger, Root Canal, Endodontic

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


[08800019100577]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-12-10
Device Publish Date2024-12-02

On-Brand Devices [Hot Testing Tip]

08800019100263HTT
08800019100577HHTT

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.