AccessGUDID - DEVICE: Advance Dental Products (00371347007107)

GUDID

Device Identifier (DI) Information

Brand Name: Advance Dental Products
Version or Model: AOGPPR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: The Atlanta Dental Supply Company

Primary DI Number: 00371347007107
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 033505389 *Terms of Use

Device Description: Advance One Gutta Percha Primary

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:	Yes
Prescription Use (Rx):	No
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?
34791	Root canal obturating point	A metallic or polymeric based point or cone suitable for use in the obturation of the dental root-canal, but not for support of a coronal restoration.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKM	GUTTA-PERCHA

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d2dedb04-2715-4999-8995-5ee9e2db224d
Public Version Date: December 16, 2022
Public Version Number: 1
DI Record Publish Date: December 08, 2022