FDA.reportPublic FDA data

Reflections®

Primary DI
10190707107106
Brand
Reflections®
Company
ORTHO ORGANIZERS, INC.
Model
REF-811
Device description
Reflections® Cer McLaughlin .022 UR2 Rx +10° Tor. +8° 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
K922499000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K922499000REFLECTIONS - CERAMIC DENTAL BRACKETCdb Corp.1992-07-30EJF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190707107109PrimaryGS10
10190707107106Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707107109001907071071091907071071090190707107109
1019070710710610190707107106

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
D82966101720900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101720900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101720900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661018200M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101820900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101920000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019200M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921000501Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0051Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0101Premium LineEC Certification Service GmbHDYW2026-06-09
D829661019210M0501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966101921900501Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000051Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000101Premium LineEC Certification Service GmbHDYW2026-06-09
D82966102020000501Premium LineEC Certification Service GmbHDYW2026-06-09