AccessGUDID - DEVICE: SCOTT'S VPS PUTTY 2-JARS REG SET (D77810480060)

GUDID

Device Identifier (DI) Information

Brand Name: SCOTT'S VPS PUTTY 2-JARS REG SET
Version or Model: 104-8006
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 104-8006
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77810480060
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: Hydroclone VPS addition cured silicone elastomeric impression material (VPS) meets or exceeds requirements for Type 1 impression materials specified by the American Dental Association Specification No. 19. Products are available in multiple viscosities (and as a putty) in both tubes and cartridges for use in various impression techniques. Hydroclone VPS is manufactured to preform according to specifications for work and set time at 73°F (23°C). Higher temperatures will decrease the work time and set time. Conversely, lower temperatures will extend work/set times. The shelf life of these materials is two years. During hot weather this material can be refrigerated to prevent degradation – but should be warmed to room temperature before use. Delivery method: two part putty, regular set, unflavored.

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:	Yes
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 73 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 600 Milliliter

Device Record Status

Public Device Record Key: ce5910a3-7d3f-4d03-850c-f85bc47163ed
Public Version Date: August 26, 2020
Public Version Number: 4
DI Record Publish Date: June 02, 2017