AccessGUDID - DEVICE: Procelain Conditioner (00190746007835)

GUDID

Device Identifier (DI) Information

Brand Name: Procelain Conditioner
Version or Model: 001-966
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 001-966
Company Name: AMERICAN ORTHODONTICS CORPORATION

Primary DI Number: 00190746007835
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 044668515 *Terms of Use

Device Description: PORCELAIN CONDITIONER 6 CC

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?
31750	Orthodontic bracket adhesive	A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
DYH	ADHESIVE, BRACKET AND TOOTH CONDITIONER, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K961417	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
Special Storage Condition, Specify: Keep Away from Light
Storage Environment Temperature: between 20 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 8d4571c4-84e4-4640-86fe-9e9c62da33af
Public Version Date: July 24, 2020
Public Version Number: 4
DI Record Publish Date: November 09, 2016