FDA.report

Peerless Buccal Tube

Primary DI
10889989014683
Brand
Peerless Buccal Tube
Company
ORMCO CORPORATION
Model
340-2256
Device description
ORTHOS CM B/T LFM OSGL -10X018 RT
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
00889989014686PrimaryGS10
10889989014683Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989014686008899890146868899890146860889989014686
1088998901468310889989014683

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

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00190746197147Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197154Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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00190746197376Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197383Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
00190746197390Empower TubeAMERICAN ORTHODONTICS CORPORATIONDZD2026-03-23
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