AH Plus Jet Endodontic Sealer Starter Kit 60620115NA

GUDID D01060620115NA1

AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin. The double-barrel syringes with disposable mixing tips for intraoral use offer a more precise, convenient and faster procedure. AH Plus endodontic sealer functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.

Dentsply De Trey GmbH

Dental epoxy resin
Primary Device IDD01060620115NA1
NIH Device Record Keya2d4e867-4a43-4c82-b6fb-ff3120403c22
Commercial Distribution StatusIn Commercial Distribution
Brand NameAH Plus Jet Endodontic Sealer Starter Kit
Version Model Number60620115NA
Catalog Number60620115NA
Company DUNS315471722
Company NameDentsply De Trey GmbH
Device Count1
DM Exempttrue
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram
Weight15 Gram

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.
Storage Environment TemperatureBetween 2 Degrees Celsius and 24 Degrees Celsius
Special Storage Condition, SpecifyBetween 0 and 0 *Keep away from sunlight.

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD01060620115NA1 [Primary]

FDA Product Code

KIFRESIN, ROOT CANAL FILLING

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-04-08
Device Publish Date2025-03-31

Devices Manufactured by Dentsply De Trey GmbH

D01060620110NA1 - AH Plus Endodontic Sealer Tubes2025-04-08 AH Plus endodontic sealer in tubes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin for an
D01060620115NA1 - AH Plus Jet Endodontic Sealer Starter Kit2025-04-08AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin. The double-barrel syringes with disposable mixing tips for intraoral use offer a more precise, convenient and faster procedure. AH Plus endodontic sealer functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus endodontic sealer does not stain teeth.
D01060620115NA1 - AH Plus Jet Endodontic Sealer Starter Kit2025-04-08 AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin
D01060620118NA0 - AH Plus Jet Endodontic Sealer Syringe Refill2025-04-08 AH Plus Jet endodontic sealer in syringes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin
D0106425400 - TPH Spectra ST2024-03-06 TPH Spectra ST Effects is a visible light-cured, radiopaque, composite restorative for anterior and posterior restorations and c
D0106425410 - TPH Spectra ST2024-03-06 TPH Spectra ST and TPH Spectra ST Effects are visible light-cured, radiopaque, composite restorative for anterior and posterior
D0106425420 - TPH Spectra ST2024-03-06 TPH Spectra ST Effects Compules Tips Intro Kit is a visible light-cured, radiopaque, composite restorative for anterior and post
D0106425430 - TPH Spectra ST2024-03-06 TPH Spectra ST Effects Compules Tips Refill D1 is a visible light-cured, radiopaque, composite restorative for anterior and post
D0106425440 - TPH Spectra ST2024-03-06 TPH Spectra ST Effects Compules Tips Refill D3 is a visible light-cured, radiopaque, composite restorative for anterior and post

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