FDA.reportPublic FDA data

Envision

Primary DI
00190707000752
Brand
Envision
Company
Ortho Organizers, Inc.
Model
701-021-5
Device description
Envision .018 UR2 8T 9A 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
00190707000752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707000752001907070007521907070007520190707000752

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
00190707133207Band Assemblies900-123061E-0202025-07-07
00190707134341Band Assemblies900-124061E-0202025-07-07
00190707140021Band Assemblies900-103061E-032025-07-07
00190707140366Band Assemblies900-104061E-032025-07-07
00190707141387Band Assemblies900-123061E-032025-07-07
00190707141516Band Assemblies900-124061E-032025-07-07
00190707192976Aria® Expressions®716-303CH-102026-08-27
00190707192983Aria® Expressions®716-304CH-102026-08-27
00190707192990Aria® Expressions®716-321CH-102026-08-27
00190707193003Aria® Expressions®716-322CH-102026-08-27
00190707193010Aria® Expressions®716-333CH-102026-08-27
00190707193027Aria® Expressions®716-351CH-HK-102026-08-27
00190707193034Aria® Expressions®716-352CH-HK-102026-08-27
00190707193041Aria® Expressions®716-359CH-HK-102026-08-27
00190707193058Aria® Expressions®716-360CH-HK-102026-08-27
00190707193065Aria® Expressions®716-369CH-HK-102026-08-27
00190707193072Aria® Expressions®716-370CH-HK-102026-08-27
00190707193089Aria® Expressions®716-389CH-HK-102026-08-27
00190707193096Aria® Expressions®716-390CH-HK-102026-08-27
00190707193102Aria® Expressions®716-393CH-HK-102026-08-27

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