FDA.report

Young Specialties

Primary DI
00840326416563
Brand
Young Specialties
Company
Young Innovations, Inc.
Model
900-138
Catalog number
900-138
Device description
Comfort Hook™ First Molar Weldable Convertible Buccal Tubes, Single, MBT, Lower Right, .018
Published
2024-07-31
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
DZDTUBE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00840326416563PrimaryGS10

GMDN Terms

TermDefinition
Orthodontic tubeA device used in orthodontics to attach a wire(s) or headgear to orthodontic bands bonded to the teeth. It is typically welded to an orthodontic band or bonded to a tooth. This is a single-patient device that is used for the duration of the 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
true
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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00190746197192Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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00190746197253Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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00190746197284Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197291Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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00190746197314Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197321Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197338Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197345Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197352Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197369Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197376Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197383Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197390Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197406Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23