FDA.report

The Orthodontic Store

Primary DI
10840326409289
Brand
The Orthodontic Store
Company
Young Innovations, Inc.
Model
620-200
Catalog number
620-200
Device description
LEONE HALF SCREW ** 8MM **
Published
2022-11-02
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
DYJRETAINER, SCREW EXPANSION, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10840326409289PackageGS11In Commercial Distribution
00840326409282PrimaryGS10

GMDN Terms

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
Moist Heat or Steam Sterilization

Contacts

PhoneEmail
+1 (800) 558-6684support@youngspecialties.com

Regulatory Flags

DUNS number
004193103
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10840326426200Young Specialties2000-02-102000-02-102026-01-26
10840326426217Young Specialties2000-03-102000-03-102026-01-26
10840326426224Young Specialties2000-04-102000-04-102026-01-26
10840326426231Young Specialties2000-05-102000-05-102026-01-26
10840326426248Young Specialties2000-06-102000-06-102026-01-26
10840326426255Young Specialties2000-07-102000-07-102026-01-26
10840326426262Young Specialties2000-08-102000-08-102026-01-26
10840326426279Young Specialties2000-09-102000-09-102026-01-26
10840326426286Young Specialties2000-10-102000-10-102026-01-26
10840326426293Young Specialties2000-15-102000-15-102026-01-26
00840326426302Young Specialties2000-16-102000-16-102026-01-26
10840326426316Young Specialties2000-17-102000-17-102026-01-26
10840326426323Young Specialties2000-18-102000-18-102026-01-26
10840326426330Young Specialties2000-19-102000-19-102026-01-26
10840326426347Young Specialties2000-20-102000-20-102026-01-26
10840326426354Young Specialties2000-21-102000-21-102026-01-26
10840326426361Young Specialties2000-22-102000-22-102026-01-26
10840326426378Young Specialties2000-23-102000-23-102026-01-26
10840326426385Young Specialties2000-24-102000-24-102026-01-26
10840326426392Young Specialties2000-25-102000-25-102026-01-26

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