FDA.reportPublic FDA data

Seamfree Single Syringe with Tips

Primary DI
00850194007336
Brand
Seamfree Single Syringe with Tips
Company
Vista Dental
Model
1
Catalog number
104-01
Device description
Seamfree Single Syringe with Tips
Published
2016-06-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EBFMaterial, Tooth Shade, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBFMaterial, Tooth Shade, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092539000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092539000SEAMFREEApex Dental Materials, Inc.2009-10-01EBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850194007336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850194007336008501940073368501940073360850194007336

GMDN Terms#

Term, Definition table
TermDefinition
Dental restorative unfilled resin kit, standardA collection of standard equipment and supplies intended to be used to fill dental cavities or restore damaged dental tissue with unfilled resin, such as polymethylmethacrylate (PMMA), that does not contain or contains very small amounts of inert filler materials. It typically includes dental cannulae (tips), finishing discs, polishing paste, polishing cups, and a tips gun. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
036623932
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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00818207020840ZrP Syringe Kit905782021-01-29
10818207024920Endo Sealer Solvent3170332026-04-22
10818207024944Endo Sealer Solvent Sample317033-M2026-04-22
00850194007862Desensify12019-12-13
00850194007893Omni Etch Ceramic Etch and Silane12019-12-13
10818207024937EdgeUtopi BC Solvent 108182070249372025-03-17
10818207025071Endocator Starter Kit4077302025-11-07
10818207025088Endocator Swabs (20pk)4077312025-11-07
10818207025064ReminGelRGEL30002025-10-09
10818207020205Vista-Cal Standard Kit5026002018-07-31
10818207020878Velvet Etch 5033152021-05-13
30818207020872Velvet Etch 5033002021-05-13
00850194007787Purify+ Gel 5 Pack12019-12-13
00850194007794Purify+ Liquid 5 Pack12019-12-13
00850194007954Purify+ Gel Single Pack12019-12-13
00850194007961Purify+ Liquid Single Pack12019-12-13
20818207020202Vista-Cal Refill Kit5026012018-07-31
00850194007466RE-GEN Cleanser1907192016-06-16

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Primary DI, Brand, Company table
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