AccessGUDID - DEVICE: Orthalgenat® (J011150520300)

GUDID

Device Identifier (DI) Information

Brand Name: Orthalgenat®
Version or Model: 150-520-30
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number:
Company Name: DENTAURUM GmbH & Co.KG

Primary DI Number: J011150520300
Issuing Agency: HIBCC
Commercial Distribution End Date: March 10, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 315427286 *Terms of Use

Device Description: Orthalgenat® Duo, Impression material, berry / 20 x 1 kg

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?
35863	Alginate dental impression material	A material containing alginate as an essential gel-forming ingredient, which, after mixing with water, reaches a consistency suitable for taking impressions of a patient's teeth and gums, or other oral anatomy. The material is placed on an impression tray and inserted into the mouth. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELW	MATERIAL, IMPRESSION

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K942666	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: Orthalgenat® Duo should be stored dry and at room temperature (max.25 °C / 77 °F). Always reseal the container after each use.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 60d5f756-55ee-4cf4-bd4a-b3d2bb4eb51d
Public Version Date: March 10, 2020
Public Version Number: 4
DI Record Publish Date: May 13, 2017