FDA.reportPublic FDA data

Origin Beyond Plus Pre-shaded multi

Primary DI
D960BPMC1141
Brand
Origin Beyond Plus Pre-shaded multi
Company
B & D DENTAL CORP.
Model
98D14mm C1
Catalog number
30112209
Device description
Origin Beyond Plus Pre-shaded multi are dental mill blanks made from zirconium dioxide for the manufacture of dental prostheses. Origin Beyond Plus Pre-shaded multi can be used for all dental constructions include bridges over 4 units with up to two connected pontics in the front and side tooth area.
Published
2020-07-21
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
D960BPMC1141PrimaryHIBCC0

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
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
D960BPX00281Origin Beyond Plus white98D28mm301116092020-07-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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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