FDA.reportPublic FDA data

Alexander SpiritMB

Primary DI
00889989061680
Brand
Alexander SpiritMB
Company
ORMCO CORPORATION
Model
740-0238
Device description
Single Patient Kit - Upper/ Lower 5x5
Published
2016-09-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
00889989061680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989061680008899890616808899890616800889989061680

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
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
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
false

Other Devices From This Company#

Primary DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D82966501520000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501520000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501520000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665015200M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966501620000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665016200M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503110000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031100M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503111000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665031110M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503210000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0051Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0101Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032100M0501Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000051Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000101Premium LineEC Certification Service GmbHDYW2026-05-26
D82966503211000501Premium LineEC Certification Service GmbHDYW2026-05-26
D829665032110M0051Premium LineEC Certification Service GmbHDYW2026-05-26