AccessGUDID - DEVICE: N.A. (J0111631131000)

GUDID

Device Identifier (DI) Information

Brand Name: N.A.
Version or Model: 163-113-10
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J0111631131000
Issuing Agency: HIBCC
Commercial Distribution End Date: January 09, 2025
Device Count: 1
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: CONTEC lc primer / adhesive / For CONTEC lc bracket adhesive (REF 163-111-00) and CONTEC lcr retainer adhesive (REF 161-131-00).

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 [?]
K030644	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: Store at 4-28°C/39-82°F/Protect from strong light or intense heat. Light sensitive. If room temp. exceeds 28°C/82 °F, store in refrigerator. Do not deep-freeze.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a0a88816-a148-4e03-ad96-265ff62c9267
Public Version Date: January 09, 2025
Public Version Number: 2
DI Record Publish Date: April 02, 2019