AccessGUDID - DEVICE: Self Cure Activator (D002634354K1)

GUDID

Device Identifier (DI) Information

Brand Name: Self Cure Activator
Version or Model: 634354K
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 634354K
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D002634354K1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Self Cure Activator Refill Package

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":	Yes
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?
34782	Dentine bonding agent/set	A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	AGENT, TOOTH BONDING, RESIN

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
Special Storage Condition, Specify: Do not freeze.
Special Storage Condition, Specify: Inadequate storage conditions will shorten the shelf life and may lead to the product malfunctioning.
Special Storage Condition, Specify: Refrigerated storage is not required, but is acceptable when not in use.
Special Storage Condition, Specify: Protect from moisture.
Storage Environment Temperature: between 2 and 24 Degrees Celsius
Special Storage Condition, Specify: Keep out of direct sunlight and store in a well ventilated place at room temperature not exceeding 25° C.
Special Storage Condition, Specify: Allow material to reach room temperature prior to use.
Special Storage Condition, Specify: Do not use after expiration date.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 Bottle (4.5 mL)

Device Record Status

Public Device Record Key: d435cddb-c083-4f17-8d1c-52d20a6d962e
Public Version Date: February 16, 2024
Public Version Number: 2
DI Record Publish Date: September 22, 2022