FDA.reportPublic FDA data

GUM®

Primary DI
00070942751469
Brand
GUM®
Company
SUNSTAR AMERICAS, INC.
Model
800
Catalog number
CQA
Device description
RED-COTE® Plaque Disclosing Tablets
Published
2021-08-29
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYHPlaque Disclosing Kit
QJCPlaque Disclosing Agent

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYHPlaque Disclosing KitDental2
QJCPlaque Disclosing AgentDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10070942751466PackageGS1248In Commercial Distribution
00070942751469PrimaryGS10
80070942751465Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007094275146610070942751466
00070942751469000709427514690709427514690070942751469
8007094275146580070942751465

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Depth3.65Millimeter
Height10.4Millimeter
Width10.4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature077 Degrees Fahrenheit
Handling Environment Temperature0 Degrees Fahrenheit77 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)777-3101contact.us@us.sunstar.com
+1(800)777-3101contact.us@us.sunstar.com

Regulatory Flags#

DUNS number
025066358
Device count
4
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070942005425GUM®4100UTWA2023-06-14
00070942005432GUM®4100UTBA2023-06-14
00070942008822GUM® Expanding Floss2030R42026-05-01
00070942008952GUM® Professional Clean Floss1820RA2026-04-30
00070942783354GUM®9934RA2024-03-12
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERS853PA2025-11-04
00070942007368GUM Technique Sensitive Clean527TPA12025-08-15
00070942007412GUM Technique Sensitive Clean527TRA22025-08-15
00070942008099GUM Technique Sensitive Clean527CNL2025-08-15
10070942007365GUM Technique Sensitive Clean527TPA12025-08-15
10070942007419GUM Technique Sensitive Clean527TRA22025-08-15
20070942008093GUM Technique Sensitive Clean527CNL2025-08-15
00070942008112GUM Technique Deep Clean5255252025-05-19
00070942006378GUM Technique Sensitive Clean524TPA1524TPA12025-05-19
00070942008105GUM Technique Sensitive Clean524CNL524CNL2025-05-19
20070942006372GUM Technique Sensitive Clean524TPA1524TPA12025-05-19
20070942008109GUM Technique Sensitive Clean524CNL524CNL2025-05-19
20070942008116GUM Technique Deep Clean5255252025-05-19
00070942006255GUM®625RQ2022-11-10
00070942002783GUM®228RQT2022-11-10

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
10860011755408CaviSenseCavisense Inc.QJC2024-10-22
06976287180831Portable Electro-Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYH2024-07-18
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