FDA.report

SpiritMB

Primary DI
00889989007183
Brand
SpiritMB
Company
ORMCO CORPORATION
Model
494-1320
Device description
ID L - Twin - Upper-Right Cuspid-Hook - Green
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

Related Records

Contact Domains

Product Codes

CodeName
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications

CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889989007183PrimaryGS10
10889989007180Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889989007183008899890071838899890071830889989007183
1088998900718010889989007180

GMDN Terms

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

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+18008541741ormcocustcare@ormco.com

Regulatory Flags

DUNS number
154614119
Device count
5
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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 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
10190707106086OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106093OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106109OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106116OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106123OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106130OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106147OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106154OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106161OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106178OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106185OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106192OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106208OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106215OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106222OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106239OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106246OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106253OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106260OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106277OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106284OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106291OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106307OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106314OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106321OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106338OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106345OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106352OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106369OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26
10190707106376OrthoFlex™ORTHO ORGANIZERS, INC.DYW2025-09-26