FDA.reportPublic FDA data

Rickonator

Primary DI
D82853004020
Brand
Rickonator
Company
FIVE STAR ORTHODONTIC LABORATORY & SUPPLY INC
Model
5300402
Published
2022-12-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DZCWire, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DZCWire, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D82853004020PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Removable dental occlusal splint, custom-madeA rigid or flexible custom-made device intended to overlay the occlusal surfaces of the teeth to maintain the position of displaced or moveable teeth, to treat teeth clenching and bruxism and their sequelae, and to provide temporary relief from muscle or temporomandibular joint (TMJ) pain (e.g., from TMJ dysfunction). It is removable by the patient (e.g., during meals), and is typically made of synthetic polymer materials and manufactured to meet the needs of an individual patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
113352686
Device count
1
Premarket exempt
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D82850001900Twin Block50001902022-12-30
D82851006000Tri-Aligner51006002023-02-13
D82851001560Bioliner Plus51001562023-02-10
D82850001910Removable Rickonator50001912023-01-13
D82853003720LVI Anterior Remodeling Appliance53003722023-01-13
D82852000100Incisor Blocks52000102023-01-03
D82853003010Snap Fit RPE53003012022-12-28
D82853000300Distal Shoe Space Maintainer53000302022-12-13
D82853002850Self-Activating Memory RPE53002852022-12-13
D82853002890Memory RPE53002892022-12-13
D82853002930RPE53002932022-12-13
D82853002950Skeletal Expander53002952022-12-13
D82853002980Bilateral Leone Distalizer53002982022-12-13
D82853002990Unilateral Expander53002992022-12-13
D82853003000Bondable R.P.E. - No Bands53003002022-12-13
D82853003110Haas Appliance53003112022-12-13
D82853003330Five Star Fixed Expander - Upper53003332022-12-13
D82853003340Five Star Mixed Dent Expander- Upper53003342022-12-13
D82853003350Five Star Mixed Dent Expander- Lower53003352022-12-13
D82853003370Super Screw Fixed Expander53003372022-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810042124882OSEORTHODONTIC SUPPLY & EQUIPMENT COMPANY INCDZC2026-10-27
00190707195014Retainer WireOrtho Organizers, Inc.DZC2026-10-20
05056389639589Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639596Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639602Pg SupplyPg Supply, Inc.DZC2026-09-28
05056389639619Pg SupplyPg Supply, Inc.DZC2026-09-28
J011520120000Noninium®DENTAURUM GmbH & Co.KGDZC2026-09-04
00840456209363JMUJMU DENTAL, INCDZC2026-06-24
00840456209370JMUJMU DENTAL, INCDZC2026-06-24
00840456209387JMUJMU DENTAL, INCDZC2026-06-24
00840456209394JMUJMU DENTAL, INCDZC2026-06-24
00840456209400JMUJMU DENTAL, INCDZC2026-06-24
00840456209417JMUJMU DENTAL, INCDZC2026-06-24
00840456209424JMUJMU DENTAL, INCDZC2026-06-24
00840456209431JMUJMU DENTAL, INCDZC2026-06-24
00840456209448JMUJMU DENTAL, INCDZC2026-06-24
00840456209455JMUJMU DENTAL, INCDZC2026-06-24
00840456209462JMUJMU DENTAL, INCDZC2026-06-24
00840456209479JMUJMU DENTAL, INCDZC2026-06-24
00840456209486JMUJMU DENTAL, INCDZC2026-06-24
00840456209493JMUJMU DENTAL, INCDZC2026-06-24
00840456209509JMUJMU DENTAL, INCDZC2026-06-24
00840456209516JMUJMU DENTAL, INCDZC2026-06-24
00840456209523JMUJMU DENTAL, INCDZC2026-06-24
00840456209530JMUJMU DENTAL, INCDZC2026-06-24
00840456209547JMUJMU DENTAL, INCDZC2026-06-24
00840456209554JMUJMU DENTAL, INCDZC2026-06-24
00840456209561JMUJMU DENTAL, INCDZC2026-06-24
00840456209578JMUJMU DENTAL, INCDZC2026-06-24
00840456209585JMUJMU DENTAL, INCDZC2026-06-24