FDA.reportPublic FDA data

zumax

Primary DI
06945095544098
Brand
zumax
Company
Zumax Medical Co., LTD
Model
10-0017
Catalog number
10-0017
Published
2026-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ELAInstrument, Hand, Calculus Removal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELAInstrument, Hand, Calculus RemovalDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06945095544098PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06945095544098069450955440986945095544098

GMDN Terms#

Term, Definition table
TermDefinition
Dental/maxillofacial surgical procedure kit, non-medicated, reusableA collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
421348837
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06945095527749zumaxOMS3200228V3742-292026-07-06
06945095527756zumaxOMS3200228V3740-292026-07-06
06945095527763zumaxOMS3000 Pro820110-10152-0002026-07-06
06945095527787zumaxOMS3500237-04102026-07-06
06945095527794zumaxOMS2380820110-10154-0002026-07-06
06945095527817zumaxOMS3500820111-10105-0002026-07-06
06945095527848zumaxOMS2350230V0041-002026-07-06
06945095527879zumaxOMS3500 Max820111-10107-0002026-07-06
06945095527886zumaxOMS2350230-0047-002026-07-06
06945095527893zumaxOMS3500820111-10109-0002026-07-06
06945095527909zumaxOMS2050252V0742-R5-282026-07-06
06945095527916zumaxOMS2380283V2850-002026-07-06
06945095527954zumaxOMS3200832100053762-292026-07-06
06945095528005zumaxOMS3200Pro323V3842-002026-07-06
06945095528012zumaxOMS3200Pro323V375N-002026-07-06
06945095528029zumaxOMS2380820110-10169-0002026-07-06
06945095528036zumaxOMS3200321V0041-002026-07-06
06945095528043zumaxOMS2380820110-10171-0002026-07-06
06945095528050zumaxOMS3000 Pro227V374N-002026-07-06
06945095528067zumaxOMS3200Pro323V37602026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810132809446House Brand DentistryFrontier Dental Supply IncELA2026-02-10
00810132809439House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00810132809453House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00810132809460House Brand DentistryFrontier Dental Supply IncELA2025-05-14
00047701001813DentekDenTek Oral Care, Inc.ELA2024-06-19
ESAM1820001STOMA®Storz am Mark GmbHELA2020-08-27
ESAM1825001STOMA®Storz am Mark GmbHELA2020-08-27
ESAM1826001STOMA®Storz am Mark GmbHELA2020-08-27
00840018624139NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625068NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625235NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625242NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625259NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625266NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018625273NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-24
00840018616851NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616868NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616875NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616882NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616899NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616905NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616912NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616929NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616936NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616943NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616950NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616967NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616974NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616981NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12
00840018616998NORDENT MANUFACTURING INCNORDENT MANUFACTURING INCELA2020-08-12