FDA.reportPublic FDA data

OrthoFlex™

Primary DI
10190707106505
Brand
OrthoFlex™
Company
ORTHO ORGANIZERS, INC.
Model
COM-762
Device description
OrthoFlex™ Com McLaughlin018 LL4 Hk Rx -12° Tor. +2° Ang.(10PK)
Published
2025-09-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DYWBRACKET, PLASTIC, ORTHODONTIC

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K973776000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K973776000REFLECTIONSCdb Corp.1997-11-21DYW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707106508PrimaryGS10
10190707106505Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707106508001907071065081907071065080190707106508
1019070710650510190707106505

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
062165188
Device count
10
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
true
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
00190707089078Endura Plus Instruments201-1212020-07-13
00190707000738Envision701-005-52016-09-24
00190707000745Envision701-006-52016-09-24
00190707000752Envision701-021-52016-09-24
00190707000769Envision701-022-52016-09-24
00190707000776Envision701-033-52016-09-24
00190707000783Envision701-034-52016-09-24
00190707000790Envision701-035-52016-09-24
00190707000806Envision701-036-52016-09-24
00190707000813Envision701-037-52016-09-24
00190707000820Envision701-038-52016-09-24
00190707000837Envision701-057-52016-09-24
00190707000844Envision701-058-52016-09-24
00190707000851Envision701-059-52016-09-24
00190707000868Envision701-060-52016-09-24
00190707000875Envision701-067-52016-09-24
00190707000882Envision701-068-52016-09-24
00190707000899Envision701-069-52016-09-24
00190707000905Envision701-070-52016-09-24
00190707000912Envision701-087-52016-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D829661019100M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019100M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019100M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966101911000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966101911000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966101911000501Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019110M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019110M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661019110M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102010000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102010000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102010000501Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020100M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020100M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020100M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102011000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102011000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102011000501Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020110M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020110M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661020110M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102710000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102710000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102710000501Premium LineEC Certification Service GmbHDYW2026-06-02
D829661027100M0051Premium LineEC Certification Service GmbHDYW2026-06-02
D829661027100M0101Premium LineEC Certification Service GmbHDYW2026-06-02
D829661027100M0501Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102711000051Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102711000101Premium LineEC Certification Service GmbHDYW2026-06-02
D82966102711000501Premium LineEC Certification Service GmbHDYW2026-06-02