FDA.reportPublic FDA data

Bite-Bumper™

Primary DI
J011705000000
Brand
Bite-Bumper™
Company
DENTAURUM GmbH & Co.KG
Model
705-000-00
Device description
Bite-Bumper™ - Palatal bite raiser for raising a deep overbite in Class II treatment
Published
2016-09-15
Public version status
Update
Distribution status
Not 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
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011705000000PrimaryHIBCC0
J011705000001Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, metalA metallic device that is bonded to an orthodontic band, or directly to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00No special storage conditions required

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)523-3946info@dentaurum-us.com

Regulatory Flags#

DUNS number
315427286
Device count
10
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011790261020equilibrium®790-261-022016-09-15
J011250001400ceraMotion®250-001-402016-09-15
J011250002200ceraMotion®250-002-202016-09-15
J011250002400ceraMotion®250-002-402016-09-15
J011250003200ceraMotion®250-003-202016-09-15
J011250003400ceraMotion®250-003-402016-09-15
J011250004200ceraMotion®250-004-202016-09-15
J011250004400ceraMotion®250-004-402016-09-15
J011250005200ceraMotion®250-005-202016-09-15
J011250005400ceraMotion®250-005-402016-09-15
J011250006200ceraMotion®250-006-202016-09-15
J011250006400ceraMotion®250-006-402016-09-15
J011250018200ceraMotion®250-018-202016-09-15
J011250019200ceraMotion®250-019-202016-09-15
J011250021200ceraMotion®250-021-202016-09-15
J011250021400ceraMotion®250-021-402016-09-15
J011250022200ceraMotion®250-022-202016-09-15
J011250022400ceraMotion®250-022-402016-09-15
J011250023200ceraMotion®250-023-202016-09-15
J011250023400ceraMotion®250-023-402016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D8294104C1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294210TL1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294210TLE1Premium LineEC Certification Service GmbHDYW2026-07-09
D8294221C1Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102721000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944102821900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103120900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103121900501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000101Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220000501Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220900051Premium LineEC Certification Service GmbHDYW2026-07-09
D82944103220900101Premium LineEC Certification Service GmbHDYW2026-07-09