AccessGUDID - DEVICE: BONASIL A+ Regular (05206569000146)

GUDID

Device Identifier (DI) Information

Brand Name: BONASIL A+ Regular
Version or Model: Regular Set, 50ml
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: DMP DENTAL INDUSTRY S.A.

Primary DI Number: 05206569000146
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 728534814 *Terms of Use

Device Description: Addition curing vinyl polysiloxane impression material

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?
35866	Silicone dental impression material	An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being 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 [?]
Premarket Submission Number Not Available/Not Released

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 10 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 3e3b52bd-9aa0-43ea-8b6e-1f9d2a6ad9a1
Public Version Date: March 30, 2021
Public Version Number: 4
DI Record Publish Date: September 24, 2016

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Status	Package Type
05206569490022	4	05206569000146	In Commercial Distribution	Box
05206569490015	2	05206569000146	In Commercial Distribution	Box
05206569001518	32	05206569000146	In Commercial Distribution	Box
05206569002188	2	05206569000146	In Commercial Distribution	Box starter pack