AccessGUDID - DEVICE: Skyrock M P/L Core Build Up Material (D83610151)

GUDID

Device Identifier (DI) Information

Brand Name: Skyrock M P/L Core Build Up Material
Version or Model: 1015
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1015
Company Name: DENT ZAR, INC.

Primary DI Number: D83610151
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789664455 *Terms of Use

Device Description: • Skyrock M is a paste/liquid system. • Well-balanced x-ray opacity permits easy distinguishing from tooth structure, pins and posts. • It is moldable and non-sticky yet has an adhesive consistency. • Allows one to control consistency, wherever desirable, by adding more or less liquid. • Contains moderately hard filler for easier carving and shaping. • Does not require refrigeration: long shelf life at ambient temperatures. • Standard Skyrock M kit comes in two shades: one is contrasting, for easy distinguishing from tooth structure; the other is natural, for use under semi-transparent ceramics.

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:	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?
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 [?]
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: 61059881-e397-41f8-8ec4-c5aabcdef602
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 03, 2016