FDA.reportPublic FDA data

Hyrax

Primary DI
J011602834120
Brand
Hyrax
Company
DENTAURUM GmbH & Co.KG
Model
602-834-12
Device description
hyrax click Maxi - 12 (ohne Arme)
Published
2022-06-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
J011602834120PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic palate expander screw, bondedAn orthodontic device intended to be used as part of a bonded palate expander to gradually spread the maxillary arch to create space for teeth alignment. It is in the form of a threaded rod with expandable pins of various lengths; it is intended to remain in the oral cavity for the duration of treatment (fixed), and may be periodically adjusted by an orthodontist to affect skeletal and/or dental changes. This is a single-patient device intended to be used for the duration of treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
315427286
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J011302112000tomas®302-112-002026-09-30
J011302114000tomas®302-114-002026-09-30
J011302212000tomas®302-212-002026-09-30
J011302214000tomas®302-214-002026-09-30
J011250301010ceraMotion®250-301-012026-09-25
J011250306010ceraMotion®250-306-012026-09-25
J011254012040ceraMotion®254-012-042026-09-25
J011254014040ceraMotion®254-014-042026-09-25
J011302150000tomas®302-150-002026-09-04
J011302250000tomas®302-250-002026-09-04
J011520120000Noninium®520-120-002026-09-04
J011621040000Noninium®621-040-002026-09-04
J011621404000Noninium®621-404-002026-09-04
J011621407000Noninium®621-407-002026-09-04
J011130131000N.A.130-131-002020-08-28
J011130137000N.A.130-137-002020-08-28
J011130138000N.A.130-138-002020-08-28
J011130324000N.A.130-324-002020-08-28
J011130634000N.A.130-634-002020-08-28
J011262411100Carmen®262-411-102016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82944S01520300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000051Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000101Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000501Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000051Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000101Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01520300051Premium LineEC Certification Service GmbHDYW2026-07-30
D82944S01520300101Premium LineEC Certification Service GmbHDYW2026-07-30
D829480001C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480002C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480003C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480005C1Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000101Premium LineEC Certification Service GmbHDYW2026-07-30