AccessGUDID - DEVICE: AH Plus Endodontic Sealer Tubes (D01060620110NA1)

GUDID

Device Identifier (DI) Information

Brand Name: AH Plus Endodontic Sealer Tubes
Version or Model: 60620110NA
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60620110NA
Company Name: Dentsply De Trey GmbH

Primary DI Number: D01060620110NA1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315471722 *Terms of Use

Device Description: AH Plus endodontic sealer in tubes is a two-component paste-paste permanent root canal sealer based on epoxy-amine resin for an easy manual mix. It 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

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KIF	RESIN, ROOT CANAL FILLING

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: Keep away from sunlight.
Storage Environment Temperature: between 2 and 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 8 Milliliter

Device Record Status

Public Device Record Key: c7d9b1e4-49c6-49ee-b2f1-a8a95f2b6dc6
Public Version Date: April 08, 2025
Public Version Number: 1
DI Record Publish Date: March 31, 2025