AccessGUDID - DEVICE: ALPHA II® AP (D73510206010020)

GUDID

Device Identifier (DI) Information

Brand Name: ALPHA II® AP
Version or Model: 102.0601.002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 102.0601.002
Company Name: DENTAL TECHNOLOGIES, INC.

Primary DI Number: D73510206010020
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 148312838 *Terms of Use

Device Description: Alpha II® AP is a radiopaque fluoride containing light-cure micro-hybrid restorative composite. The special combination of fillers form a material that is extremely durable and wear-resistant; making it ideal for Class I and II restorations yet highly polishable for use in all Class III, IV and V restorations. Alpha II® AP has optimal handling characteristics. The material can be easily manipulated without sticking to your instruments. Alpha II® contains fluorescence to provide a duplication of the natural tooth surface. Kit contains: 1 x 4.5g Composite Syringe (Shade B1)

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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K904813	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
Storage Environment Temperature: between 2 and 27 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 2e9ec148-d64d-47ff-a0d1-6e56752f07ab
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 23, 2016