AccessGUDID - DEVICE: STANDBY ALGINATE ALTERNATIVE 50ml CART 4/pk (D77810463011)

GUDID

Device Identifier (DI) Information

Brand Name: STANDBY ALGINATE ALTERNATIVE 50ml CART 4/pk
Version or Model: 104-6301
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 104-6301
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77810463011
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 4
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: Alginate Alternative is an addition cured elastomeric vinyl impression material specifically formulated to be used as an alternative to traditional alginate materials. Intended to be used primarily for taking impressions for case study models, temporary crown and bridge fabrication, partial denture impression, Orthodontic models and counter impressions .Alginate Alternative is a non-toxic material that, when set, is chemically resistant. For SDS and instructions for use visit https://www.scottsdental.com/impression-material/alginate-substitutes/standby-alginate-alternative.html

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):	No
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: less than 72 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 50 Milliliter

Device Record Status

Public Device Record Key: eb00ad13-6a8d-4acb-8cb7-212947f606a4
Public Version Date: August 26, 2020
Public Version Number: 3
DI Record Publish Date: October 25, 2018