FDA.reportPublic FDA data

T-Scan Novus

Primary DI
B970DN10
Brand
T-Scan Novus
Company
Tekscan, Inc.
Model
T-Scan System
Catalog number
DN1
Device description
T-Scan Windows Software, 1 Novus Handpiece (USB Connection), 20 Large & 20 Small Sensors, 2 Large & 2 Small Sensor Supports, 1 Novus Handpiece Holder, 3 Adhesive Strips, 90 Day Free Customer Support, One Year Parts & Labor Warranty, Interactive Help File, Electronic Operations Manual.
Published
2020-11-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EFHPaper, Articulation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EFHPaper, ArticulationDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B970DN10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental articulation paperA strip or sheet of suitable material coated with pigment and used for marking areas of contact between opposite teeth, restorations or appliances. This is a single-use device.

Regulatory Flags#

DUNS number
178180246
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B970FG2PRO0F-Scan GOF-Scan GO System with FootVIEW ProFG2PRO2024-03-14
B970FG20F-Scan GOF-Scan GO SystemFG22024-03-01
B970TD2000TekDAQ 200TekDAQ 200TD-2002024-03-01
B97030101250F-Scan GO 3010 Sensor3010-1252023-11-29
B9703000E12503000-E-125 F-Scan Sensor3000-E-125 F-Scan Sensor3000-E-1252020-11-03
B9703000E5003000-E-50 F-Scan Sensor3000-E-50 F-Scan Sensor3000-E-502020-11-03
B9703000ES03000-E-S F-Scan Sensor3000-E-S F-Scan Sensor3000-E-S2020-11-03
B9703000SPORTE12503000SPORT-E-125 F-Scan Sensor3000SPORT-E-125 F-Scan Sensor3000SPORT-E-1252020-11-03
B9703000SPORTE5003000SPORT-E-50 F-Scan Sensor3000SPORT-E-50 F-Scan Sensor3000SPORT-E-502020-11-03
B9703000SPORTES03000SPORT-E-S F-Scan Sensor3000SPORT-E-S F-Scan Sensor3000SPORT-E-S2020-11-03
B9703001E12503001-E-125 F-Scan Sensor3001-E-125 F-Scan Sensor3001-E-1252020-11-03
B9703001ES03001-E-S F-Scan Sensor3001-E-S F-Scan Sensor3001-E-S2020-11-03
B9703001SPORTE12503001SPORT-E-125 F-Scan Sensor3001SPORT-E-125 F-Scan Sensor3001SPORT-E-1252020-11-03
B9703001SPORTES03001SPORT-E-S F-Scan Sensor3001SPORT-E-S F-Scan Sensor3001SPORT-E-S2020-11-03
B9703005E12503005E- F-Scan XL Sport Left & Right Sensor (Sold as a pair only - price reflects3005E- F-Scan XL Sport Left & Right Sensor (Sold a3005E-1252020-11-03
B970302012503020-125 Sensor3020-125 Sensor3020-1252020-11-03
B97030221250Sensor, Matrix 3022-125Sensor, Matrix 3022-1253022-1252020-11-03
B970302412503024-125 Sensor3024-125 Sensor3024-1252020-11-03
B97030261250Sensor,Matrix,3026-125Sensor,Matrix,3026-1253026-1252020-11-03
B970302812503028-125 Senor3028-125 Sensor3028-1252020-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D040600001ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
D040600011ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
D040600071ARDENTWHIP-MIX CORPORATIONEFH2025-11-05
08906110440175Maarc dental - Articulating PaperSHIVA PRODUCTSEFH2024-10-02
00889813062081Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062098Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062104Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062128Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062135Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062142Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062159Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062166Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062088Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062095Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062101Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062125Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062132Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062149Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062156Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
10889813062163Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
00889813062173Darby Dental Supply, LLCDARBY DENTAL SUPPLY, LLCEFH2024-09-17
D956OCCLUFL0DSI Occlufoil 6mmD.S.I DENTAL SOLUTIONS LTDEFH2024-07-01
10732224001712Articulating PaperCROSSTEX INTERNATIONAL, INC.EFH2024-04-12
D040600081ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600130ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040602061ARDENT WHIP-MIX CORPORATIONEFH2023-10-27
D040600021ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D040600031ARDENT DISPOSABLE DENTWHIP-MIX CORPORATIONEFH2023-08-18
D248720010"Madam Butterfly Silk 3/4"" Blue"HAGER WORLDWIDE, INC.EFH2023-05-15
D248720020"Madam Butterfly Silk 3/4"" Grn"HAGER WORLDWIDE, INC.EFH2023-05-15