AccessGUDID - DEVICE: SELECT TEMPORARY FILLING MATERIAL 30 GM JAR (D77819910550)

GUDID

Device Identifier (DI) Information

Brand Name: SELECT TEMPORARY FILLING MATERIAL 30 GM JAR
Version or Model: 199-1055
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 199-1055
Company Name: SCOTT'S DENTAL SUPPLY L.L.C.

Primary DI Number: D77819910550
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 137217043 *Terms of Use

Device Description: Scott’s Select Temporary Filling material is indicated for the temporary filling of root canal access opening, cavity preparations that require temporary fillings for short periods during therapeutic treatment and temporary filling for small inlay preparations. Scotts Select Temporary filling material is a single paste that can be applied by spatula. It sets with a slight expansion to a hard material that can be removed without the use of burs. It is a non-eugenol formulation allowing it to be applied in locations where a resin such as a composite restorative or bonding system will be used in the final restorative technique. Instructions for use and SDS available at https://www.scottsdental.com/temporary-filling-material-scott-s-select.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):	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?
16705	Zinc polycarboxylate dental cement	A non-sterile substance intended for professional use as a dental cement (e.g., luting agent, liner, base) and/or direct dental restorative material whereby the majority of the setting reaction is based on the hardening reaction between zinc oxide (ZnO) and aqueous solutions of polycarboxylic acid (e.g., polyacrylic acid). It typically includes some additional fillers/components. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	Cement, Dental

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 15 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 30 Gram

Device Record Status

Public Device Record Key: 2697c4ed-50bc-487c-b74e-8fa25b4f62a2
Public Version Date: December 20, 2018
Public Version Number: 4
DI Record Publish Date: May 04, 2017