FDA.reportPublic FDA data

CaviSense

Primary DI
10860011755408
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
Rx
false
OTC
false
Sterile
false
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8332454543support@cavisense.com

Regulatory Flags#

DUNS number
111292766
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860011755401CaviSense2024102024-10-22

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
00860011755401CaviSenseCavisense 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