FDA.reportPublic FDA data

Tooth Print Wafer Sample Pack

Primary DI
00858290006314
Brand
Tooth Print Wafer Sample Pack
Company
ELEVATE ORAL CARE, LLC
Model
660TPSAMP
Device description
Tooth Print Wafer Sample Pack
Published
2019-05-30
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EGDWax, Dental, Intraoral

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EGDWax, Dental, IntraoralDental1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K850915000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K850915000WAX BITE IMPRESSION WAFERToothprints, Inc.1985-04-16EGD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858290006314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858290006314008582900063148582900063140858290006314

GMDN Terms#

Term, Definition table
TermDefinition
Saliva absorbentA non-sterile device designed to absorb moisture from the oral cavity during a dental procedure. Also known as a saliva absorber, it can be in a variety of shapes and sizes and is typically made of paper, cotton, or polymeric web, and may have a high-absorbent core. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002863526
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00858290006987Allday Oral Moisturizing Rinse, 10oz Bottle626MR10102026-05-01
00858290006970FluoriMax 2.5% NaF demo pack 630FMFT042026-01-28
00858290006802Advantage Arrest635GE30002025-07-21
00858290006819Advantage Arrest635GSP0502025-07-21
00858290006826Advantage Arrest635GSP0502025-07-21
00858290006956Advantage Arrest Advantage Arrest SDF 38% Gel Syringe 2.8ml Kit635GEL2802025-06-11
00858290006734FluoriMax Cotton CandyFlow Through Ampoule 70 pack6300070222024-12-12
00858290006918PapacariePapacarie Syringe610PAP1002024-12-12
00858290006932Povi-OnePovi-One/FluoriMax Varnish BG Convenience640POFM802024-12-12
00858290006659Elevate Tongue Cleaner Metal 6pk655METAL62021-07-28
00858290006444Smart Advantage GI Sample A1 and A2 pk675UD02002019-06-10
00858290006543Denteshield Primer 3ml Kit685PRM3002020-04-01
00858290006550Denteshield Primer 7ml Kit685PRM7002020-04-01
00858290006369Smart Advantage GI A1 ampule575CAPA1S2019-06-10
00858290006376Smart Advantage GI A2 ampoule575CAPA2S2019-06-10
00858290006352Smart Advantage GI A1 and A2 Combo kit 30 ampules675COMB002019-10-14
00858290006031Elevate Tongue Cleaner Pink 655PINK002019-01-23
00858290006598DenteShield Sample Opaque with Fluoride 685DSSAMP2020-06-11
00858290006529DenteShield Pit and Fissure Sealant Kit with Fluoride Clear685PITFTC2020-04-01
00858290006536DenteShield Pit and Fissure Sealant Kit with Fluoride Opaque685PITFTO2020-04-01

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