FDA.reportPublic FDA data

OrthoFlex™

Primary DI
10190707106581
Brand
OrthoFlex™
Company
ORTHO ORGANIZERS, INC.
Model
COM-802
Device description
OrthoFlex™ Com McLaughlin .022 UL1 Rx +17° Tor. +4° 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
00190707106584PrimaryGS10
10190707106581Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707106584001907071065841907071065840190707106584
1019070710658110190707106581

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
D82944S01520300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01620300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01720300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01820300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01920300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300051Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300101Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S02020300501Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000051Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000101Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112411000501Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000051Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000101Premium LineEC Certification Service GmbHDYW2026-07-31
D82955112511000501Premium LineEC Certification Service GmbHDYW2026-07-31
D82944S01520300051Premium LineEC Certification Service GmbHDYW2026-07-30
D82944S01520300101Premium LineEC Certification Service GmbHDYW2026-07-30
D829480001C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480002C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480003C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480005C1Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000101Premium LineEC Certification Service GmbHDYW2026-07-30