DEVICE: AH Plus Jet Endodontic Sealer Starter Kit (D01060620115NA1)
Device Identifier (DI) Information
AH Plus Jet Endodontic Sealer Starter Kit
60620115NA
In Commercial Distribution
60620115NA
Dentsply De Trey GmbH
60620115NA
In Commercial Distribution
60620115NA
Dentsply De Trey GmbH
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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66609 | Dental epoxy resin |
A substance intended for professional use as a dental root canal sealant that consists of a chemical-curing epoxy resin material(s); it does not include any additional hardening fillers/components (i.e., not a composite resin). It may be provided as a powder and/or paste intended to be mixed prior to application; dedicated disposable devices associated with application may be included with the resin. After application, this device cannot be reused.
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FDA Product Code
[?]Product Code | Product Code Name |
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KIF | RESIN, ROOT CANAL FILLING |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 24 Degrees Celsius |
Special Storage Condition, Specify: Keep away from sunlight. |
Clinically Relevant Size
[?]Size Type Text |
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Weight: 15 Gram |
Device Record Status
a2d4e867-4a43-4c82-b6fb-ff3120403c22
April 08, 2025
1
March 31, 2025
April 08, 2025
1
March 31, 2025
Alternative and Additional Identifiers Additional Identifiers
Package DI
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
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No Customer Contact currently defined