AccessGUDID - DEVICE: A2 (D798AO1)

GUDID

Device Identifier (DI) Information

Brand Name: A2
Version or Model: AO
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: AO
Company Name: RELIANCE ORTHODONTIC PRODUCTS INC

Primary DI Number: D798AO1
Issuing Agency: HIBCC
Commercial Distribution End Date: July 09, 2020
Device Count: 5
Labeler D-U-N-S® Number*: 113170088 *Terms of Use

Device Description: A2 Oval Attachment Form can be used for the retention of themoplastic aligners and for horizontal or vertical placement on the tooth depending on the height of the crown.

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):	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?
42344	Dental mould	A hollow form in which a dental material is intended to be injected, cast, or pressed to produce a particular shape.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KXR	Applicator, Resin

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: Store at ambient conditions.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2c97e97c-c75b-488b-b381-9c4e9d6d1c50
Public Version Date: July 10, 2020
Public Version Number: 3
DI Record Publish Date: July 25, 2016