FDA.reportPublic FDA data

GUM®

Primary DI
00070942302722
Brand
GUM®
Company
SUNSTAR AMERICAS, INC.
Model
832
Catalog number
RQ
Device description
ORAL CARE CLEANING KIT
Published
2022-11-10
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EAXMIRROR, MOUTH
EKBExplorer, Operative
EMNScaler, Periodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EAXMirror, MouthDental1
EKBExplorer, OperativeDental1
EMNScaler, PeriodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10070942302729PackageGS16In Commercial Distribution
00070942302722PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007094230272910070942302729
00070942302722000709423027220709423027220070942302722

GMDN Terms#

Term, Definition table
TermDefinition
Dental examination kitA collection of various dental instruments and the necessary materials (e.g., aspiration cannula, forceps, mirror, probe, spatula, excavator) intended to be used to perform a dental examination. It does not contain any pharmaceuticals and is not intended for surgical procedures. This is a single-use device.

Contacts#

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

Regulatory Flags#

DUNS number
025066358
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00070942008334GUM®875SM2026-07-28
00070942005265GUM®3615BQ2023-01-26
00070942006491GUM®3615PQA2023-12-07
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G879102124H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-23
G8791021380DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-23
G879102177H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102184H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791021850DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102185H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102186H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102187H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102191H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102196H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102197H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102211H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102212H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102213H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G8791024050DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879102RM340DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEMN2026-08-18
G879MMFS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMFSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS40DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G879MMPSCS50DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEAX2026-08-14
G8791021190DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021196L0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021200DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G8791021250DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102131H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08
G879102132H0DENSOLDENSOL INTERNATIONAL (PRIVATE) LIMITEDEKB2026-08-08