AccessGUDID - DEVICE: StoneBite® Introduction Package (E239D504872A1)

GUDID

Device Identifier (DI) Information

Brand Name: StoneBite® Introduction Package
Version or Model: D504872A
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D504872A
Company Name: Dreve Dentamid GmbH

Primary DI Number: E239D504872A1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 388000846 *Terms of Use

Device Description: No.

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:	No
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?
38602	Bite registration rim wax	A dental material (modelling wax) with or without reinforcing foils (metal, polymer) for registration of jaw relation (making bite rims). 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 [?]
K190571	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
Storage Environment Temperature: between 18 and 28 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: c6c246f0-f3e6-4927-bbd6-cb6fd4da2709
Public Version Date: October 28, 2021
Public Version Number: 1
DI Record Publish Date: October 20, 2021