AccessGUDID - DEVICE: Aladdin™ Total Self-Cure Activator (D6870099405FG1)

GUDID

Device Identifier (DI) Information

Brand Name: Aladdin™ Total Self-Cure Activator
Version or Model: 0099405FG
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 0099405FG
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D6870099405FG1
Issuing Agency: HIBCC
Commercial Distribution End Date: June 05, 2024
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Aladdin™ Total Self-Cure Activator (1 Bottle x 4.5ml)

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?
67089	Dental restorative material curing activator	A dental, dual-cured, resin-based material intended to be mixed with a light-cured bonding agent prior to its application, to promote curing (bonding) between the bonding agent and a self- or dual-cured restorative material (e.g., cement, composite resin). 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 [?]
K964525	000

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: Keep away from sunlight.

Clinically Relevant Size

[?]

Size Type Text
Device Size Text, specify: 1 Bottle Aladdin™ Self Cure Activator (4.5ml)
Total Volume: 4.5 Milliliter

Device Record Status

Public Device Record Key: f3aab69e-f901-4828-a50b-cea15c3f6aec
Public Version Date: June 05, 2024
Public Version Number: 4
DI Record Publish Date: September 21, 2016