AccessGUDID - DEVICE: L-SHA-Flowable Composite Syr. Shade A2 (D83600350)

GUDID

Device Identifier (DI) Information

Brand Name: L-SHA-Flowable Composite Syr. Shade A2
Version or Model: 0035
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 0035
Company Name: DENT ZAR, INC.

Primary DI Number: D83600350
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 789664455 *Terms of Use

Device Description: L-SHA-Light Cured Nano Particle Paint-On Restorative and Veneer Cement (Flowable Composite) L-SHA is recommended for cementing fabricated laminate veneers, restoring acrylic veneers and for use in Class III and Class V restorations, and for limited use in Class I restorations in premolars, and selected Class IV restorations where aesthetics are of primary importance. OUTSTANDING FEATURES OF THE MATERIAL High adhesive strength to etched enamel without the use of bonding agents. Superior aesthetics due to well balanced opacity and light reflectance. Excellent color stability. Reduced oxygen inhibited layer contributes to the ease of finishing. Does not require refrigeration. Shelf life in excess of two years. Fast in application–one component restorative system. Excellent flow of the material facilitates application. May be cured with any dentalcuring instrument operating in the visible range.

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 [?]
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: cd578ba2-35ed-4f50-b4aa-c7de63c5be30
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 02, 2016