AccessGUDID - DEVICE: GlasSpan Flexible Ceramic Bonding Material Standard Kit (00723896011737)

GUDID

Device Identifier (DI) Information

Brand Name: GlasSpan Flexible Ceramic Bonding Material Standard Kit
Version or Model: STANDARD KIT
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 701770
Company Name: PRACTICON, INC.

Primary DI Number: 00723896011737
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 119193803 *Terms of Use

Device Description: Contains (3) GlasSpan Flexible Ceramic Bonding Rope Small (3) GlasSpan Flexible Ceramic Bonding Rope Medium (3)GlasSpan Flexible Ceramic Bonding Rope large and (3) GlasSpan Flexible Ceramic Bonding Tape

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:	Yes
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	Yes
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?
44786	Dental reinforcing fibre	A device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of polyethylene (PE) fibres supplied in strands, braid, or ribbon in a variety of sizes. It may also be used for the stabilization of avulsed teeth maintaining diastema closures or split-tooth syndrome. The ultrahigh molecular weight PE fibres increase the strength of composite materials, and provide improved safety by assisting in the retention of pieces in the event that a dental prosthesis is broken. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
ELS	Splint, Endodontic Stabilizing

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K922673	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: de91a939-5c89-42fb-9a47-e3b7569ac9a3
Public Version Date: February 07, 2019
Public Version Number: 1
DI Record Publish Date: January 07, 2019