FDA.reportPublic FDA data

ORJ

Primary DI
D115D6011111
Brand
ORJ
Company
Fortune Worldwide LLC
Model
D601-111
Device description
Orthodontic Bands, preformed for Teeth Correction
Published
2022-11-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
ECMBand, Preformed, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ECMBand, Preformed, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D115D6011111PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic metal bandA thin metal ring designed to be fitted around the contours of a tooth and cemented into place to support an orthodontic attachment (e.g., bracket, tube), brazed or soldered onto the ring, intended to be secured to the tooth. 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
949163229
Device count
1
Premarket exempt
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D115AFA2151ORJAFA2152023-06-12
D115AFA2551ORJAFA2552023-06-12
D115GP202251ORJGP202252023-06-12
D115PP202251ORJPP202252023-06-12
D115W41112U1ORJW411-12U2023-06-12
D115W63010061ORJW630-10062022-11-08
D115W1211925U1ORJW121-1925U2022-11-04
D115TB3224001ORJTB32-24002022-10-28
D115F201021ORJF201-022023-01-23
D115F201031ORJF201-032023-01-23
D115F20104L1ORJF201-04L2023-01-23
D115F20104R1ORJF201-04R2023-01-23
D115F202021ORJF202-022023-01-23
D115F301011ORJF301-012023-01-23
D115F301021ORJF301-022023-01-23
D115F307011ORJF307-012023-01-23
D115W73014071ORJW730-14072022-11-08
D115D6012101ORJD601-2102022-11-04
D115J62151151ORJJ621-51152022-11-04
D115J62151251ORJJ621-51252022-11-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033707035763LEONE SPALEONE SPAECM2020-11-11
08033707035770LEONE SPALEONE SPAECM2020-11-11
08033707035787LEONE SPALEONE SPAECM2020-11-11
08033707035794LEONE SPALEONE SPAECM2020-11-11
08033707035800LEONE SPALEONE SPAECM2020-11-11
08033707035817LEONE SPALEONE SPAECM2020-11-11
08033707035824LEONE SPALEONE SPAECM2020-11-11
08033707035831LEONE SPALEONE SPAECM2020-11-11
08033707035848LEONE SPALEONE SPAECM2020-11-11
08033707035855LEONE SPALEONE SPAECM2020-11-11
08033707035862LEONE SPALEONE SPAECM2020-11-11
08033707035879LEONE SPALEONE SPAECM2020-11-11
08033707035886LEONE SPALEONE SPAECM2020-11-11
08033707035893LEONE SPALEONE SPAECM2020-11-11
08033707035909LEONE SPALEONE SPAECM2020-11-11
08033707035916LEONE SPALEONE SPAECM2020-11-11
08033707035923LEONE SPALEONE SPAECM2020-11-11
08033707035930LEONE SPALEONE SPAECM2020-11-11
08033707035947LEONE SPALEONE SPAECM2020-11-11
08033707035954LEONE SPALEONE SPAECM2020-11-11
08033707035961LEONE SPALEONE SPAECM2020-11-11
08033707035978LEONE SPALEONE SPAECM2020-11-11
08033707035985LEONE SPALEONE SPAECM2020-11-11
08033707035992LEONE SPALEONE SPAECM2020-11-11
08033707036005LEONE SPALEONE SPAECM2020-11-11
08033707036012LEONE SPALEONE SPAECM2020-11-11
08033707036029LEONE SPALEONE SPAECM2020-11-11
08033707036036LEONE SPALEONE SPAECM2020-11-11
08033707036043LEONE SPALEONE SPAECM2020-11-11
08033707036050LEONE SPALEONE SPAECM2020-11-11