FDA.report

Peerless Buccal Tube

Primary DI
10889989015147
Brand
Peerless Buccal Tube
Company
ORMCO CORPORATION
Model
340-6147
Device description
PEERLESS 2ND B/T 6DEG -10T 018 NDX UL
Published
2022-12-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
DZDTUBE, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DZDTube, OrthodonticDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889989015140PrimaryGS10
10889989015147Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989015140008899890151408899890151400889989015140
1088998901514710889989015147

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.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags

DUNS number
154614119
Device count
10
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
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00889989073140Tubli-Seal003402016-09-08
00889989073157Tubli-Seal010812016-09-08
00889989074116Sealapex184322016-09-08
00889989074123Sealapex185982016-09-08
00889989074130Pulp Canal Sealer EWT247452016-09-08
00889989074147Pulp Canal Sealer EWT247462016-09-08
00889989074154Pulp Canal Sealer248732016-09-08
00889989074161Pulp Canal Sealer248742016-09-08
00889989074178Pulp Canal Sealer248752016-09-08
00889989074192Tubli-Seal EWT259032016-09-08
00889989074215Sealapex Xpress336392016-09-08
00889989074222Tubli-Seal Xpress336402016-09-08
00889989074239Tubli-Seal EWT Xpress336412016-09-08
10889989088882Ormco™ EtchFree Bonding740-05002025-05-09
00889989088892Ormco™ EtchFree Bonding740-05102025-05-09
00889989088908Ormco™ EtchFree Bonding740-05202025-05-09
10889989088912Ormco™ EtchFree Bonding740-05252025-05-09
10889989012252Straight-Wire Synthesis338-03102024-03-07
10889989012269Straight-Wire Synthesis338-03112024-03-07
10889989012276Straight-Wire Synthesis338-04102024-03-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00190746197116Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197123Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197130Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197147Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197154Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197161Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197178Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197185Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197192Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197208Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197215Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197222Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197239Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197246Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197253Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197260Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197277Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197284Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197291Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197307Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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