FDA.reportPublic FDA data

breCAM.HIPC

Primary DI
EBRE540034060
Brand
breCAM.HIPC
Company
bredent GmbH & Co. KG
Model
54003406
Device description
breCAM.HIPC Ø 98,4 x 20mm C2 1 Piece
Published
2026-05-07
Public version status
New
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
ELMDenture, Plastic, Teeth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ELMDenture, Plastic, TeethDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EBRE540034060PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, combination-materialA dental material made of a combination of metal, ceramic, and/or synthetic polymer [e.g., polyethylene (PE)] 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Height20Millimeter
Outer Diameter98.4Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00keep dry
Special Storage Condition, Specify00keep out of sunlight

Contacts#

Phone, Email table
PhoneEmail
+4907309872531regulatory-affairs@bredent.com
+4907309872451info@bredent.com

Regulatory Flags#

DUNS number
341086190
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EBRE540033990breCAM.HIPC540033992026-05-07
EBRE540034010breCAM.HIPC540034012026-05-07
EBRE540021110breCAM.BioHPP54002111540021112016-09-20
EBRE540021210breCAM.BioHPP54002121540021212016-09-20
EBRE580012660Qu-resin dentin58001266580012662023-09-07
EBREVLCOLBLACK0visio.lign color BlackVLCOLBLACKVLCOLBLACK2025-03-10
EBREVLCOLBLUE0visio.lign color BlueVLCOLBLUEVLCOLBLUE2025-03-10
EBREVLCOLBODYA0visio.lign color Body AVLCOLBODYAVLCOLBODYA2025-03-10
EBREVLCOLBODYB0visio.lign color Body BVLCOLBODYBVLCOLBODYB2025-03-10
EBREVLCOLBODYC0visio.lign color Body CVLCOLBODYCVLCOLBODYC2025-03-10
EBREVLCOLBODYD0visio.lign color Body DVLCOLBODYDVLCOLBODYD2025-03-10
EBREVLCOLBROWN0visio.lign color BrownVLCOLBROWNVLCOLBROWN2025-03-10
EBREVLCOLCREME0visio.lign color CremeVLCOLCREMEVLCOLCREME2025-03-10
EBREVLCOLGLIGHT0visio.lign color Gum LightVLCOLGLIGHTVLCOLGLIGHT2025-03-10
EBREVLCOLGPINK0visio.lign color Gum PinkVLCOLGPINKVLCOLGPINK2025-03-10
EBREVLCOLGRED0visio.lign color Gum RedVLCOLGREDVLCOLGRED2025-03-10
EBREVLCOLGREYBL0visio.lign color Grey-BlueVLCOLGREYBLVLCOLGREYBL2025-03-10
EBREVLCOLOLIVE0visio.lign color OliveVLCOLOLIVEVLCOLOLIVE2025-03-10
EBREVLCOLORANGE0visio.lign color OrangeVLCOLORANGEVLCOLORANGE2025-03-10
EBREVLCOLROSE0visio.lign color RoseVLCOLROSEVLCOLROSE2025-03-10

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Primary DI, Brand, Company table
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00850070544610Midas Restore - A1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544627Midas Restore - A2 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544634Midas Restore - A3 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544641Midas Restore - B1 - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544658Midas Restore - Bleach - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544665Midas Restore - Unpigmented - Single-unit Capsule 1-PackSprintray, Inc.ELM2026-07-31
00850070544672Midas Restore - A1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544689Midas Restore - A2 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544696Midas Restore - A3 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544702Midas Restore - B1 - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544719Midas Restore - Bleach - Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
00850070544726Midas Restore - Unpigmented- Single-unit Capsule 3-PackSprintray, Inc.ELM2026-07-31
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07630813462646TCR MultiCandulor AGELM2026-07-28
07630813462653TCR MultiCandulor AGELM2026-07-28
07630813462660TCR MultiCandulor AGELM2026-07-28
07630813462677TCR MultiCandulor AGELM2026-07-28
07615208592634Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592689Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592696Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592702Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
07615208592719Ivotion DentIVOCLAR VIVADENT AKTIENGESELLSCHAFTELM2026-07-09
E235DPCS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPOMS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPSGS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
E235DPTIS0DentaprintSHOFU DENTAL CORPORATIONELM2026-06-23
EGEB290040TRIBOS 501 C Composite teeth SLA-UJ-3,5Gebdi Dental-Products GmbHELM2026-06-03