AccessGUDID - DEVICE: Mollosil Plus Glaze and Catalyst (D814FIXX41)

GUDID

Device Identifier (DI) Information

Brand Name: Mollosil Plus Glaze and Catalyst
Version or Model: FIXX4
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PROTECH PROFESSIONAL PRODUCTS INC

Primary DI Number: D814FIXX41
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 117374900 *Terms of Use

Device Description: Mollosil Plue Glaze and Catalyst (2x7ml), Silicone Glaze and Catalyst and Nipples

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?
34769	Denture reliner, elastic, short-term	A denture relining material intended to be applied by a dentist or dental laboratory technician as a temporary coating or lining on the base or tissue-contact surface of a denture and which has elastic properties after setting. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	Resin, Denture, Relining, Repairing, Rebasing

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: db970d24-5d37-47ce-8f20-3c47ca80e930
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: January 25, 2018