FDA.reportPublic FDA data

Alexander SpiritMB

Primary DI
00889989007503
Brand
Alexander SpiritMB
Company
ORMCO CORPORATION
Model
494-3055
Device description
LO CENT UNV -5T0A .018 (PK10)
Published
2016-09-08
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889989007503PrimaryGS10
10889989007500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989007503008899890075038899890075030889989007503
1088998900750010889989007500

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, plastic, single-useA plastic device intended to be bonded to a tooth, to hold an orthodontic wire and/or other appliance (e.g., rubber bands) used to apply pressure to the tooth in order to alter the position of the tooth. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags#

DUNS number
154614119
Device count
5
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889989079494Tevdek II975-00502016-09-08
00889989079500Tevdek II975-00522016-09-08
00889989079517Tevdek II975-00542016-09-08
00889989079524Tevdek II975-00562016-09-08
00889989079531Tevdek II975-00632016-09-12
00889989079548Tevdek II975-00652016-09-12
00889989079555Tevdek II975-00672016-09-12
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D829665016200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665016200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501720000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665017200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501820000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665018200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501920000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019200M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966501921000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0051Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0101Premium LineEC Certification Service GmbHDYW2026-05-28
D829665019210M0501Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000051Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000101Premium LineEC Certification Service GmbHDYW2026-05-28
D82966502020000501Premium LineEC Certification Service GmbHDYW2026-05-28
D829665020200M0051Premium LineEC Certification Service GmbHDYW2026-05-28