FDA.reportPublic FDA data

Multi M Series

Primary DI
08800155227213
Brand
Multi M Series
Company
DMAX Co.,Ltd.
Model
APA2Z14
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250826000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250826000Multi M SeriesDmax Co., Ltd.2025-06-12EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08800155227213PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08800155227213088001552272138800155227213

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
557798558
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08800155217252Multi M SeriesNAA0W102025-08-15
08800155217269Multi M SeriesW4A0W102025-08-15
08800155217276Multi M SeriesY3A0W102025-08-15
08800155217283Multi M SeriesOMA0W102025-08-15
08800155217290Multi M SeriesY5A0W102025-08-15
08800155217306Multi M SeriesP5A0W102025-08-15
08800155217313Multi M SeriesG5A0W102025-08-15
08800155217320Multi M SeriesS5A0W102025-08-15
08800155217337Multi M SeriesK3A0W102025-08-15
08800155217344Multi M SeriesK4A0W102025-08-15
08800155217351Multi M SeriesK5A0W102025-08-15
08800155217368Multi M SeriesOPA0W102025-08-15
08800155217375Multi M SeriesHMA1W202025-08-15
08800155217382Multi M SeriesHMA3W202025-08-15
08800155217399Multi M SeriesAPA0W102025-08-15
08800155217405Multi M SeriesAPA0W122025-08-15
08800155217412Multi M SeriesAPA0W142025-08-15
08800155217429Multi M SeriesAPA0W162025-08-15
08800155217436Multi M SeriesAPA0W182025-08-15
08800155217443Multi M SeriesAPA0W202025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800ZRTA09010Prettau 5 98H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09110Prettau 5 98H14 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09210Prettau 5 98H18 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09310Prettau 5 98H20 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09410Prettau 5 98H12 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09510Prettau 5 98H22 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09620Prettau 5 98H16 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA09710Prettau 5 98H25 with stepZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106100Prettau 5 106H10ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106110Prettau 5 106H11ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106120Prettau 5 106H12ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106130Prettau 5 106H13ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106140Prettau 5 106H14ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106150Prettau 5 106H15ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106160Prettau 5 106H16ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106170Prettau 5 106H17ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106180Prettau 5 106H18ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106190Prettau 5 106H19ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106200Prettau 5 106H20ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106210Prettau 5 106H21ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106220Prettau 5 106H22ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106230Prettau 5 106H23ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106240Prettau 5 106H24ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106250Prettau 5 106H25ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106260Prettau 5 106H26ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106270Prettau 5 106H27ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106280Prettau 5 106H28ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106290Prettau 5 106H29ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106300Prettau 5 106H30ZIRKONZAHN SRLEIH2026-09-18
D800ZRTA106310Prettau 5 106H31ZIRKONZAHN SRLEIH2026-09-18