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
00070942007160GUM®888PCRX2026-10-08
07640164360072GUIDORC11-0082015-10-22
07640164360089GUIDORC11-0182015-10-22
07640164360096GUIDORC11-0782015-10-22
07640164360140GUIDORC11-0072015-10-22
10070942003695GUM® CRAYOLA TWISTABLES FLOSSERS853PA, PX2025-11-04
10070942751572GUM®2014PQ, PQA, PQB2022-11-10
10070942751619GUM®1115PQA; PQBX2022-11-10
70070942751703GUM®3210PQX2022-11-10
00070942302159GUM®1812RQTX2022-11-10
00070942306515GUM®897RQ75, RZDX2022-11-10
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
00070942007368GUM Technique Sensitive Clean527TPA12025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840456225424JMUJMU DENTAL, INCEAX2026-10-14
00840456225431JMUJMU DENTAL, INCEAX2026-10-14
00840161312174Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
00840161312181Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
00840161312198Crystal HD® Mouth MirrorsZIRC DENTAL PRODUCTS, INC.EAX2026-10-12
00840456224861JMUJMU DENTAL, INCEMN2026-09-30
00840456224878JMUJMU DENTAL, INCEMN2026-09-30
00840456224885JMUJMU DENTAL, INCEMN2026-09-30
00840456224892JMUJMU DENTAL, INCEMN2026-09-30
00840456224908JMUJMU DENTAL, INCEMN2026-09-30
00840456224915JMUJMU DENTAL, INCEMN2026-09-30
D955MM5CSFS1Paul BandittTerlain Enterprises, Inc.EAX2026-09-25
06973042242995Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243008Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243015Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243022Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243039Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243053Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243060Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243077Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243084Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243091Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
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06973042243121Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243138Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243145Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243152Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30
06973042243169Ultrasonic Scaler TipsGuilin Veirun Medical Technology Co., Ltd.EMN2026-08-30