FDA.reportPublic FDA data

GlasSpan Flexible Ceramic Bonding Material Standard Kit

Primary DI
00723896011737
Brand
GlasSpan Flexible Ceramic Bonding Material Standard Kit
Company
PRACTICON, INC.
Model
STANDARD KIT
Catalog number
701770
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
Published
2019-01-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ELSSplint, Endodontic Stabilizing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELSSplint, Endodontic StabilizingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K922673000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922673000FLEXIBLE CERAMIC ROPES AND TAPES FOR BONDINGGlasspan, Inc.1994-02-25ELS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00723896011737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00723896011737007238960117377238960117370723896011737

GMDN Terms#

Term, Definition table
TermDefinition
Dental reinforcing fibreA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
119193803
Device count
1
Combination product
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00723896029848Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029879Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029909Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030288ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030318ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030349ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08
00723896030370ECOsply™ Biodegradable Disposable Impression Trays Medium Lower 10/Pack715825271582522026-01-08
00723896030400ECOsply™ Biodegradable Disposable Impression Trays Small Upper 10/Pack715825371582532026-01-08
00723896030431ECOsply™ Biodegradable Disposable Impression Trays Small Lower 10/Pack715825471582542026-01-08
00723896030462ECOsply™ Biodegradable Disposable Impression Trays Quadrant UR/LL 10/Pack715825571582552026-01-08
00723896030493ECOsply™ Biodegradable Disposable Impression Trays Quadrant UL/LR 10/Pack715825671582562026-01-08
00723896030523ECOsply™ Biodegradable Disposable Impression Trays Anterior Upper 10/Pack715825771582572026-01-08
00723896030554ECOsply™ Biodegradable Disposable Impression Trays Anterior Lower 10/Pack715825871582582026-01-08
00723896030585ECOsply™ Biodegradable Disposable Impression Trays Assortment 10/Pack715825971582592026-01-08
00723896029855Practicon Color Splash™ Saliva Ejectors 100/Pack715824771582472026-01-08
00723896029886Practicon Bliss™ Level 3 Face Mask 50/Box Black7158246 BLA7158246 BLA2026-01-08
00723896029916Practicon Bliss™ Level 3 Face Mask 50/Box Blue7158246 BLU7158246 BLU2026-01-08
00723896030295ECOsply™ Biodegradable Disposable Impression Trays Large Upper 10/Pack715824971582492026-01-08
00723896030325ECOsply™ Biodegradable Disposable Impression Trays Large Lower 10/Pack715825071582502026-01-08
00723896030356ECOsply™ Biodegradable Disposable Impression Trays Medium Upper 10/Pack715825171582512026-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10723896011772GlasSpan Flexible Ceramic Bonding Rope Small RefillPRACTICON, INC.ELS2018-08-24
10723896011789GlasSpan Flexible Ceramic Bonding Rope Medium RefillPRACTICON, INC.ELS2018-08-24
10723896011796GlasSpan Flexible Ceramic Bonding Rope Large RefillPRACTICON, INC.ELS2018-08-24
10723896011802GlasSpan Flexible Ceramic Bonding TapePRACTICON, INC.ELS2018-08-24
D844G112GlasSpan Dental FiberGLASSPAN INCELS2016-09-21
D844G213GlasSpan Dental FiberGLASSPAN INCELS2016-09-21
D844G314GlasSpan Dental FiberGLASSPAN INCELS2016-09-21
D844G415GlasSpan Dental FiberGLASSPAN INCELS2016-09-19