FDA.reportPublic FDA data

Origin

Primary DI
D960LVX00281
Brand
Origin
Company
B & D DENTAL CORP.
Model
Live 28mm
Catalog number
30101108
Device description
Origin Live are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Live can be used for all dental constructions incl. bridges over 4 units with up to two connected pontics in the front and side tooth area.
Published
2020-06-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110719000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110719000ORIGIN ZIRCONIAB&D Dental Technologies2011-08-11EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D960LVX00281PrimaryHIBCC0

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

Contacts#

Phone, Email table
PhoneEmail
801-281-4012sale@bnddental.com

Regulatory Flags#

DUNS number
151552994
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D960BPMA1141Origin Beyond Plus Pre-shaded multi98D14mm A1301122002020-07-21
D960BPMA2141Origin Beyond Plus Pre-shaded multi98D14mm A2301122012020-07-21
D960BPMA3141Origin Beyond Plus Pre-shaded multi98D14mm A3301122022020-07-21
D960BPMA4141Origin Beyond Plus Pre-shaded multi98D14mm A4301122042020-07-21
D960BPMA5141Origin Beyond Plus Pre-shaded multi98D14mm A3.5301122032020-07-21
D960BPMB1141Origin Beyond Plus Pre-shaded multi98D14mm B1301122052020-07-21
D960BPMB2141Origin Beyond Plus Pre-shaded multi98D14mm B2301122062020-07-21
D960BPMB3141Origin Beyond Plus Pre-shaded multi98D14mm B3301122072020-07-21
D960BPMB4141Origin Beyond Plus Pre-shaded multi98D14mm B4301122082020-07-21
D960BPMC1141Origin Beyond Plus Pre-shaded multi98D14mm C1301122092020-07-21
D960BPMC2141Origin Beyond Plus Pre-shaded multi98D14mm C2301122102020-07-21
D960BPMM2141Origin Beyond Plus Pre-shaded multi98D14mm OM2301121992020-07-20
D960BPX00121Origin Beyond Plus white98D12mm301116012020-07-20
D960BPX00141Origin Beyond Plus white98D14mm301116022020-07-20
D960BPX00161Origin Beyond Plus white98D16mm301116032020-07-20
D960BPX00181Origin Beyond Plus white98D18mm301116042020-07-20
D960BPX00201Origin Beyond Plus white98D20mm301116052020-07-20
D960BPX00221Origin Beyond Plus white98D22mm301116062020-07-20
D960BPX00241Origin Beyond Plus white98D24mm301116072020-07-20
D960BPX00251Origin Beyond Plus white98D25mm301116082020-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28