AccessGUDID - DEVICE: Orthocryl® (J011161136000)

GUDID

Device Identifier (DI) Information

Brand Name: Orthocryl®
Version or Model: 161-136-00
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J011161136000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: Orthocryl® liquid, neon orange / 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?
65679	Orthodontic palate expander/teeth aligner, self-removable	An orthodontic device intended to gradually spread the maxillary arch and/or improve teeth alignment. It is typically in the form of either: 1) a segmented body separated by a palate expander screw; or 2) a spring-like mechanism with clasps and/or wires. It is not fixed to the oral cavity so that it can be temporarily removed and reapplied by the patient during the treatment period (e.g., for eating). This is a reusable device.	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: Keep in a closed bottle / 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: 8a1fc75b-fa17-43bf-88f1-e86cf582909c
Public Version Date: November 16, 2021
Public Version Number: 6
DI Record Publish Date: March 25, 2017

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: Yes
Serial Number: No
Expiration Date: Yes
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +1(800)523-3946
Email: info@dentaurum-us.com

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