FDA.reportPublic FDA data

Ortek Therapeutics, Inc.

Primary DI
00858197004062
Brand
Ortek Therapeutics, Inc.
Company
ORTEK THERAPEUTICS, INC
Model
Ortek-ECD
Published
2022-12-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LFCDevice, Caries Detection
NBLLaser, Fluorescence Caries Detection

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LFCDevice, Caries DetectionDental2
NBLLaser, Fluorescence Caries DetectionDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170822000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170822000Electronic Caries DetectorOrtek Therapeutics, Inc.2017-09-11NBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858197004062PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858197004062008581970040628581970040620858197004062

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detector, electrical impedanceA mains electricity (AC-powered) device designed to measure resistance to the flow of electric current across teeth for the diagnosis of early stage dental caries and/or to monitor the progress of caries (carious areas being less resistant due to higher concentrations of fluid). It typically consists of a probe with an electrode placed in contact with the tooth to be tested and a second counter electrode, separate from the probe, which is placed in contact with another part of the patient's body to complete an electrical circuit; and an electronic control unit that quantifies the resistance. This procedure is also known as electronic caries monitoring/measurement (ECM).

Regulatory Flags#

DUNS number
849786749
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
E27668082030Primescan 2SIRONA Dental Systems GmbHNBL2025-11-21
E27668082450Primescan 2SIRONA Dental Systems GmbHNBL2025-10-23
E27668053651Primescan 2 Multiuse SleeveSIRONA Dental Systems GmbHNBL2025-09-16
E27668558402Primescan 2SIRONA Dental Systems GmbHNBL2025-08-20
05902729754149TRIOS 53shape Trios A/SNBL2025-06-16
E27668020400Primescan 2SIRONA Dental Systems GmbHNBL2025-05-16
05902729753906TRIOS Ready Tip3shape Trios A/SNBL2025-05-06
06977585090143Fluorescence ModeCarl Zeiss Meditec (Suzhou) Co., Ltd.NBL2025-03-26
09359621000021BlueCheckINCISIVE TECHNOLOGIES PTY LTDLFC2025-02-26
04262352350035DI ScanZetta25 AGNBL2025-02-21
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-12-03
08800043200090AIOBIOAIOBIO CO.,LTDNBL2024-12-02
09359621000038BlueCheckINCISIVE TECHNOLOGIES PTY LTDLFC2024-11-20
09359621000014BlueCheckINCISIVE TECHNOLOGIES PTY LTDLFC2024-11-20
08809941490008SmartoothSmartooth Co., Ltd.NBL2024-07-22
08809941490121SmartoothSmartooth Co., Ltd.NBL2024-07-22
08809941490084SmartoothSmartooth Co., Ltd.NBL2024-07-22
03760278267587ACTEONSOPRONBL2024-05-02
EKAV101112130DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
EKAV101315000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-02-01
00817051021690ExposeCENTRIX, INC.LFC2023-12-22
00817051021706ExposeCENTRIX, INC.LFC2023-12-22
00817051021744ExposeCENTRIX, INC.LFC2023-12-22
00817051022338ExposeCENTRIX, INC.LFC2023-12-22
00817051022345ExposeCENTRIX, INC.LFC2023-12-22
00817051022352ExposeCENTRIX, INC.LFC2023-12-22
00817051022369ExposeCENTRIX, INC.LFC2023-12-22
05902729753661TRIOS3shape Trios A/SNBL2022-09-26
05902729753753TRIOS3shape Trios A/SNBL2022-09-26
05902729753746TRIOS3shape Trios A/SNBL2022-09-26