breCAM.HIPC 54003446

GUDID EBRE540034469

breCAM.HIPC Ø 95 x 20mm ZZ C2 1 Piece

bredent GmbH & Co. KG

Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material Dental appliance fabrication material, combination-material

• Primary Device ID: EBRE540034469
• NIH Device Record Key: 97d207bd-7cf8-4ed6-b7fc-44547a3ecdd8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: breCAM.HIPC
• Version Model Number: 54003446
• Catalog Number: 54003446
• Company DUNS: 341086190
• Company Name: bredent GmbH & Co. KG
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com
• Phone: +4907309872531
• Email: regulatory-affairs@bredent.com

Device Dimensions

• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter
• Outer Diameter: 95 Millimeter
• Height: 20 Millimeter

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry
• Special Storage Condition, Specify: Between 0 and 0 *keep out of sunlight
• Special Storage Condition, Specify: Between 0 and 0 *keep dry

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EBRE540034460 [Primary]
HIBCC	EBRE540034469 [Package]; Contains: EBRE540034460; Package: dummy [1 Units]; Discontinued: 2023-08-31; Not in Commercial Distribution

FDA Product Code

• ELM: Denture, plastic, teeth

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-09-08
• Device Publish Date: 2023-08-31

On-Brand Devices [breCAM.HIPC]

• EBRE540034509: breCAM.HIPC Ø 95 x 20mm ZZ clear 1 Piece
• EBRE540034499: breCAM.HIPC Ø 95 x 20mm ZZ D3 1 Piece
• EBRE540034489: breCAM.HIPC Ø 95 x 20mm ZZ D2 1 Piece
• EBRE540034479: breCAM.HIPC Ø 95 x 20mm ZZ C3 1 Piece
• EBRE540034469: breCAM.HIPC Ø 95 x 20mm ZZ C2 1 Piece
• EBRE540034459: breCAM.HIPC Ø 95 x 20mm ZZ B3 1 Piece
• EBRE540034449: breCAM.HIPC Ø 95 x 20mm ZZ B2 1 Piece
• EBRE540034439: breCAM.HIPC Ø 95 x 20mm ZZ A4 1 Piece
• EBRE540034429: breCAM.HIPC Ø 95 x 20mm ZZ A3.5 1 Piece
• EBRE540034419: breCAM.HIPC Ø 95 x 20mm ZZ A3 1 Piece
• EBRE540034409: breCAM.HIPC Ø 95 x 20mm ZZ A2 1 Piece
• EBRE540034399: breCAM.HIPC Ø 95 x 20mm ZZ A1 1 Piece
• EBRE540034389: breCAM.HIPC Ø 95 x 20mm ZZ bleach 1 Piece
• EBRE540033989: breCAM.HIPC Ø 98.4 x 20mm bleach 1 Piece