FDA.reportPublic FDA data

Purzir

Primary DI
00810087761714
Brand
Purzir
Company
Seattle Bioceramics, Inc.
Model
HT Plus ML A1 98-18
Device description
Purzir Dental Zirconia Blank
Published
2021-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193055000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193055000Purzir Dental Zirconia3DBiocad2020-05-13EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810087761714PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810087761714008100877617148100877617140810087761714

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
118155468
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810087769925PürzirMMT Plus A1 98-222022-02-21
00810087769932PürzirMMT Plus A2 98-222022-02-21
00810087769949PürzirMMT Plus A3 98-222022-02-21
00810087769956PürzirMMT Plus A3.5 98-222022-02-21
00810087769963PürzirMMT Plus B1 98-222022-02-21
00810087769970PürzirMMT Plus B2 98-202022-02-21
00810087769987PürzirMMT Plus C2 98-202022-02-21
00810087769994PürzirMMT Plus C1 98-202022-02-21
00810087764166PürzirMMT Plus A2 98-252022-02-18
00810087764173PürzirMMT Plus A1 98-252022-02-18
00810087764180PürzirMMT Plus A3 98-252022-02-18
00810087764197PürzirMMT Plus A3.5 98-252022-02-18
00810087764203PürzirMMT Plus A4 98-142022-02-18
00810087764210PürzirMMT Plus A4 98-162022-02-18
00810087764227PürzirMMT Plus A4 98-182022-02-18
00810087764234PürzirMMT Plus A4 98-202022-02-18
00810087764241PürzirMMT Plus A4 98-222022-02-18
00810087764258PürzirMMT Plus A4 98-252022-02-18
00810087764265PürzirMMT Plus B1 98-252022-02-18
00810087764272PürzirMMT Plus B2 98-222022-02-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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EDMC32613087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32623024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32623087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32633024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32633087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32643087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32653087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32663087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32673024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32673087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32683024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
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EDMC32693024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32693087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32703087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32713098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32723098180NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733024240NaceraDOCERAM medical ceramics GmbHEIH2022-05-16
EDMC32733087870NaceraDOCERAM medical ceramics GmbHEIH2022-05-16