AccessGUDID - DEVICE: DENTASTIC UNO (D701UNO2)

GUDID

Device Identifier (DI) Information

Brand Name: DENTASTIC UNO
Version or Model: UNO
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: PULPDENT CORPORATION

Primary DI Number: D701UNO2
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 001006089 *Terms of Use

Device Description: SINGLE COMPONENT DENTAL ADHESIVE, LIGHT CURE UNO Kit: 2 x 6 mL bottles Dentastic UNO, 5 mL etch gel, 20 APPLICATOR TIPS, 50 BRUSH TIPS, BRUSH HANDLE

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?
42483	Dentine adhesive	A material primarily used as a bonding-promoting substance between dentine and a composite filling, restorative or luting material. It may also be used as a bonding substance to enamel. After application, this device cannot be reused.	Obsolete	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 01b5ea06-56e7-416f-8dd3-e1e6905e7e2b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: July 21, 2016