FDA.reportPublic FDA data

CaviSense

Primary DI
00860011755401
Brand
CaviSense
Company
Cavisense Inc.
Model
202410
Device description
Plaque disclosing device
Published
2024-10-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QJCPlaque Disclosing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QJCPlaque Disclosing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860011755408PackageGS116In Commercial Distribution
00860011755401PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086001175540810860011755408
00860011755401008600117554018600117554010860011755401

GMDN Terms#

Term, Definition table
TermDefinition
Dental caries detecting stainA liquid substance intended for use in dentistry as a staining agent to detect early stage dental caries and/or to monitor the progress of caries. It typically consists of two solutions (e.g., metal fluorides) that are applied separately to the suspect area of the tooth/teeth, and change colour in the presence of the caries-producing bacteria or bacterial residues, and/or remnants of the tooth structure from a carious lesion. The staining produced can be monitored over time to assess the progression/remission of the caries. After application, this device cannot be reused.

Contacts#

Phone, Email table
PhoneEmail
8332454543support@cavisense.com

Regulatory Flags#

DUNS number
111292766
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10860011755408CaviSense2024102024-10-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D2486056550Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-20
D2486056621Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-20
D2486057651Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-20
D2486057681Quick-DetectHAGER WORLDWIDE, INC.QJC2025-10-08
00302732311028Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322000Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322109Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732322253Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732330043Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732342008Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732342107Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732342251Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732957189Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
20302732311022Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
20302732322004Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732322106Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732322250Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732330040Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
00302732331026Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
20302732342002Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732342104Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732342258Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10302732957186Young DentalYOUNG DENTAL MANUFACTURING I, LLCQJC2025-02-17
10860011755408CaviSenseCavisense Inc.QJC2024-10-22
00840326405949Young InnovationsYoung Innovations, Inc.QJC2024-03-11
07640159162797DISCLOSING TABLETS - 100 piecesProduits dentaires S.A.QJC2022-06-15
07640159162803DISCLOSING TABLETS - 1'000 piecesProduits dentaires S.A.QJC2022-06-15
07640159162810DISCLOSING TABLETS - 500 piecesProduits dentaires S.A.QJC2022-06-15
00070942751469GUM®SUNSTAR AMERICAS, INC.QJC2021-08-29
00723797010419HurriViewBEUTLICH PHARMACEUTICALS, LLCQJC2019-10-01