FDA.reportPublic FDA data

palex®

Primary DI
J011602811010
Brand
palex®
Company
DENTAURUM GmbH & Co.KG
Model
602-811-01
Device description
palex® Maxi - 12, straight / RPE screw / For further information please visit our online-shop on our website www.dentaurum.de
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
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J011602811010PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic teeth positioner, preformedA prefabricated dental device, typically made of plastic, that is an impression of a perfected bite used to prevent a patient's teeth from shifting position, or to move teeth to a final position, after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position. This is a reusable device.

Storage And Handling#

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

Contacts#

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

Regulatory Flags#

DUNS number
315427286
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
J011250024200ceraMotion®250-024-202016-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033707104513LEONE SPALEONE SPADYJ2026-05-28
00840456221761JMUJMU DENTAL, INCDYJ2026-05-11
00840456221778JMUJMU DENTAL, INCDYJ2026-05-11
D775AHAD0Hawley Retainer with Adams ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMMT0MemotainGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
00197998216633Clarity™Solventum Orthodontics CorporationDYJ2026-04-25
10371347023326Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023333Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023340Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023357Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
D775AEA0Expansion ApplianceGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775AH0Hawley RetainerGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775BKS0Keles SliderGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
00190746202766PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-04-08
08033707104827LEONE SPALEONE SPADYJ2026-04-01
08033707104834LEONE SPALEONE SPADYJ2026-04-01
08800197901621ATOZ KeyMK Meditech Inc.DYJ2025-11-03
J011430120310prime4me®DENTAURUM GmbH & Co.KGDYJ2025-10-09
J011430120410prime4me®DENTAURUM GmbH & Co.KGDYJ2025-10-09
07895742296612MorelliDental Morelli LtdaDYJ2025-09-10
07895742296629MorelliDental Morelli LtdaDYJ2025-09-10
07895742296636MorelliDental Morelli LtdaDYJ2025-09-10
07895742296643MorelliDental Morelli LtdaDYJ2025-09-10
J011430120400prime4me®DENTAURUM GmbH & Co.KGDYJ2025-07-10
J01854551HerbstScheu-Dental GmbHDYJ2024-11-19