AccessGUDID - DEVICE: Orthocryl® (J011160007000)

GUDID

Device Identifier (DI) Information

Brand Name: Orthocryl®
Version or Model: 160-007-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J011160007000
Issuing Agency: HIBCC
Commercial Distribution End Date: November 18, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: Orthocryl® Neon powder, neon yellow/ orthodontic acrylics

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?
33592	Orthodontic teeth positioner, preformed	A prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a reusable device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
KMY	POSITIONER, TOOTH, PREFORMED

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942667	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 in a closed container / Protect from contamination and sunlight as they may cause premature polymerisation.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 269e587f-5120-44d9-a3a1-3bb39ec52653
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 15, 2016