AccessGUDID - DEVICE: VISCOGEL (D010616050021)

GUDID

Device Identifier (DI) Information

Brand Name: VISCOGEL
Version or Model: 61605002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 61605002
Company Name: Dentsply De Trey GmbH

Primary DI Number: D010616050021
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 315471722 *Terms of Use

Device Description: VISCO GEL Standard Pack is a self-curing, resilient methacrylate formulation, intended for use as a limited-term soft linig material for complet and partial dentures. Visco-gel is received in 2 components powder (D010K2006000) and liquid (D010K3006010) both of them in a bottle delivery. With an additional bottle of a separator (D010K3006020) and its supporting accessories (Mixing Bowl, Powder Measure and Liquid Measure) it can be classified as a convenience kit.

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?
17610	Denture reliner, soft, professional	A denture relining material used in dentistry by a dentist or dental laboratory technician that is applied as a permanent coating or lining on the base or tissue-contacting surface of a denture and which sets to a soft, plastic condition. Denture relining is defined as a process of providing a new fitting surface to a denture (ISO 1942-2, def 2.111). 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: Yes 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 24 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 120 Gram
Device Size Text, specify: Liquid
Total Volume: 15 Milliliter
Total Volume: 90 Milliliter
Device Size Text, specify: Powder

Device Record Status

Public Device Record Key: 806c6f3d-e4cc-47fd-9617-ab7ee8c1a83a
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 20, 2016