AccessGUDID - DEVICE: Orthocryl® (J011160403000)

GUDID

Device Identifier (DI) Information

Brand Name: Orthocryl®
Version or Model: 160-403-00
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J011160403000
Issuing Agency: HIBCC
Commercial Distribution End Date: June 02, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: Orthocryl® LC, red/ 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?
65677	Orthodontic palate expander screw, bonded	An orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.	Active	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: Close cartridges after use / Store in a cool environment (not above 25 °C/ 77°F) and protect from contamination and sunlight as they may cause premature polymerization.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 78dc79d9-4a45-4d31-beb8-c50fef1f589d
Public Version Date: October 21, 2022
Public Version Number: 7
DI Record Publish Date: September 15, 2016