FDA.reportPublic FDA data

Envision

Primary DI
00190707000899
Brand
Envision
Company
Ortho Organizers, Inc.
Model
701-069-5
Device description
Envision .018 LR3 HK -11T 5A 0O
Published
2016-09-24
Public version status
Update
Distribution status
Not 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
00190707000899PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707000899001907070008991907070008990190707000899

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
1
DM exempt
true
Lot or batch
true

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
00190707000905Envision701-070-52016-09-24
00190707000912Envision701-087-52016-09-24
00190707000929Envision701-088-52016-09-24

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