AccessGUDID - DEVICE: Acorn Single Dose Caps. Sh. C2 (D83600281)

GUDID

Device Identifier (DI) Information

Brand Name: Acorn Single Dose Caps. Sh. C2
Version or Model: 0028
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0028
Company Name: DENT ZAR, INC.

Primary DI Number: D83600281
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 10
Labeler D-U-N-S® Number*: 789664455 *Terms of Use

Device Description: Acorn composite suitable for: Class III, IV, V, as well as, class I and II restorations. Fabrication of extra orally tempered inlays-and onlays by the direct or indirect method, as well as, fabrication of extraorally tempered custom made veneers. A highly polishable, photocuring, Nano-Micro Hybrid composite for anterior and posterior restorations.

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:	Yes
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 [?]
K960565	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 9ed3ddfd-7c46-45c3-94c7-fb8c82fbfa30
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: September 02, 2016