FDA.reportPublic FDA data

Inspire

Primary DI
08800025400135
Brand
Inspire
Company
GOOD DOCTORS CO., LTD.
Model
IC-WHCD100
Device description
Laser, Fluorescence Caries Detection
Published
2020-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
NBLLaser, Fluorescence Caries Detection

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183471000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183471000IC-WHCD100 (Inspire)Good Doctors Co., Ltd.2020-07-02NBL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
18800025400132PackageGS11In Commercial Distribution
08800025400135PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
1880002540013218800025400132
08800025400135088000254001358800025400135

GMDN Terms#

Term, Definition table
TermDefinition
Intraoral optical scanning systemAn assembly of electronic devices intended to use optical technology to capture digital topographical 3-D images of teeth, oral cavity structure and geometry, and bite relationship of a patient; it is typically in addition capable of detecting dental caries. It consists of a hand-held intraoral scanner with near infrared (NIR) and laser illumination, and a mobile unit with a user interface with display/controls. The resulting digital dental impressions may be used for CAD/CAM fabrication of dental restorations and orthodontic devices.

Regulatory Flags#

DUNS number
688201036
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800025400692EZ SHOT SEIC-EZSE102026-01-15
08800025400159Dr.s cam VIC-DCCU742020-01-16
08800025400173EZ SHOT HD VIC-EZBU822020-01-16
08800025400456Dr's Light PRIMECL-DP402023-08-24
08800025400463Dr's Light CHOICECL-DP402023-08-24
08800025400524File Hook(1pcs)AC04012023-08-23
08800025400531Lip Hook(3pccs)AC04072023-08-23
18800025400156Dr.s cam VIC-DCCU742020-01-16
18800025400170EZ SHOT HD VIC-EZBU822020-01-16
08800025400296Charger_DLDLT030M20012019-11-26
08800025400203Charger_Drs Light ClaverDC020M10012019-11-22
08800025400210Battery_Drs Light ClaverCL02001102019-11-22
08800025400227Guide-cap_Drs Light ClaverCL02002102019-11-22
08800025400234Disposable cover_35x100_wideIC06002202019-11-22
08800025400241Disposable cover_60x200_wideIC06002302019-11-22
08800025400258Disposable cover_35x100_narrowIC06002102019-11-22
08800025400265Disposable cover_46x195_wide/100 pcsIC06002302019-11-22
08800025400289Disposable cover_60x280_narrowIC06002502019-11-22
08800025400012Whicam Story3_wirelessIC-WHT602019-10-30
08800025400029Whicam Story3_wiredIC-WHW612019-10-30

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
04262352350035DI ScanZetta25 AGNBL2025-02-21
EKAV101537000DIAGNOcam Vision Full HDKaVo Dental GmbHNBL2024-12-03
08800043200090AIOBIOAIOBIO CO.,LTDNBL2024-12-02
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
00858197004062Ortek Therapeutics, Inc. ORTEK THERAPEUTICS, INCNBL2022-12-21
05902729753661TRIOS3shape Trios A/SNBL2022-09-26
05902729753753TRIOS3shape Trios A/SNBL2022-09-26
05902729753746TRIOS3shape Trios A/SNBL2022-09-26
05902729753678TRIOS3shape Trios A/SNBL2022-09-26
05902729753685TRIOS3shape Trios A/SNBL2022-09-26
05902729753722TRIOS 53shape Trios A/SNBL2022-09-26
05902729753739TRIOS 53shape Trios A/SNBL2022-09-26
05902729753760TRIOS3shape Trios A/SNBL2022-09-26
05902729753777TRIOS3shape Trios A/SNBL2022-09-26
05902729753784TRIOS3shape Trios A/SNBL2022-09-26
E247J27121CamX Spectra Interchangeable HeadDÜRR DENTAL SENBL2022-03-04
03760278260304ACTEONSOPRONBL2019-03-13