FDA.reportPublic FDA data

OrthoFlex

Primary DI
00190730002167
Brand
OrthoFlex
Company
ORTHO TECHNOLOGY, INC.
Model
COM-801
Device description
OrtFlx Com McLaughlin 022 UR1 Rx +17º Tor. +4º Ang.(10PK)
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
00190730002167PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190730002167001907300021671907300021670190730002167

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
781772017
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190730000088Resilience5010092016-09-24
00190730000095Resilience5032042016-09-24
00190730000101Resilience5061012016-09-24
00190730000118Resilience5061022016-09-24
00190730000125Resilience5061042016-09-24
00190730000132Resilience5061062016-09-24
00190730000149Resilience5061072016-09-24
00190730084538Clear Advantage7500-1002025-07-24
00190730084545Clear Advantage7500-1052025-07-24
00190730084552Clear Advantage7500-1102025-07-24
00190730084569Clear Advantage7500-0352025-07-24
00190730084576Clear Advantage7500-0402025-07-24
00190730084583Sports Advantage7500-1652025-07-24
00190730084590Sports Advantage7500-1402025-07-24
10190730084535Clear Advantage7500-1002025-07-24
10190730084542Clear Advantage7500-1052025-07-24
10190730084559Clear Advantage7500-1102025-07-24
10190730084566Clear Advantage7500-0352025-07-24
10190730084573Clear Advantage7500-0402025-07-24
10190730084580Sports Advantage7500-1652025-07-24

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