FDA.reportPublic FDA data

LightForce Orthodontic System

Primary DI
00860270000953
Brand
LightForce Orthodontic System
Company
LIGHTFORCE ORTHODONTICS, INC.
Model
08.23.18.1.PCA.TBW.WJ
Device description
Patient Specific Orthodontic Brackets with Indirect Bonding Jigs and SoftwareMaterial: Polycrystalline Alumina
Published
2018-08-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860270000953PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860270000953008602700009538602700009530860270000953

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic bracket, ceramicA ceramic device intended to be bonded to a tooth to hold an orthodontic archwire used to apply pressure to the tooth in order to alter the position of the tooth. It typically has a metal (e.g., stainless steel) insert slot for the archwire, which is held in place with an orthodontic archwire/bracket fixation ring. This is a single-patient device intended to be used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
096883072
Device count
1
DM exempt
true
Kit
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850079555587FlexBracket09.01.25.PCA.FB.UL1.0222025-10-14
00850079555594FlexBracket09.01.25.PCA.FB.UL2.0222025-10-14
00850079555600FlexBracket09.01.25.PCA.FB.UL3.0222025-10-14
00850079555617FlexBracket09.01.25.PCA.FB.UL4.0222025-10-14
00850079555624FlexBracket09.01.25.PCA.FB.UL5.0222025-10-14
00850079555631FlexBracket09.01.25.PCA.FB.UL6.0222025-10-14
00850079555648FlexBracket09.01.25.PCA.FB.UL7.0222025-10-14
00850079555655FlexBracket09.01.25.PCA.FB.UR1.0222025-10-14
00850079555662FlexBracket09.01.25.PCA.FB.UR2.0222025-10-14
00850079555679FlexBracket09.01.25.PCA.FB.UR3.0222025-10-14
00850079555686FlexBracket09.01.25.PCA.FB.UR4.0222025-10-14
00850079555693FlexBracket09.01.25.PCA.FB.UR5.0222025-10-14
00850079555709FlexBracket09.01.25.PCA.FB.UR6.0222025-10-14
00850079555716FlexBracket09.01.25.PCA.FB.UR7.0222025-10-14
00850079555723FlexBracket09.01.25.PCA.FB.LL1.0222025-10-14
00850079555730FlexBracket09.01.25.PCA.FB.LL2.0222025-10-14
00850079555747FlexBracket09.01.25.PCA.FB.LL3.0222025-10-14
00850079555754FlexBracket09.01.25.PCA.FB.LL4.0222025-10-14
00850079555761FlexBracket09.01.25.PCA.FB.LL5.0222025-10-14
00850079555778FlexBracket09.01.25.PCA.FB.LL6.0222025-10-14