AccessGUDID - DEVICE: ADSEAL Plus Auto-Mix (08806387894780)

GUDID

Device Identifier (DI) Information

Brand Name: ADSEAL Plus Auto-Mix
Version or Model: 9478
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Meta Biomed Co., Ltd.

Primary DI Number: 08806387894780
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 688322841 *Terms of Use

Device Description: ADSEAL Plus root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of two components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator. The ADSEAL Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.

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:	No
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 [?]
K230010	000

Device Exempt from Premarket Submission: No 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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 640b4046-78b9-4dbd-996b-ebb67b48a06a
Public Version Date: June 19, 2023
Public Version Number: 1
DI Record Publish Date: June 09, 2023