FDA.report

Carriere® SLX® 3D EZ Twist™

Primary DI
00190707072001
Brand
Carriere® SLX® 3D EZ Twist™
Company
ORTHO ORGANIZERS, INC.
Model
201-510
Device description
Carriere® SLX® 3D EZ Twist™ Opener
Published
2020-07-13
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
false

Related Records

Product Codes

CodeName
DZNINSTRUMENTS, DENTAL HAND

Product Code Classifications

CodeDeviceSpecialtyClass
DZNInstruments, Dental HandDental1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00190707072001PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00190707072001001907070720011907070720010190707072001

GMDN Terms

TermDefinition
Self-ligating orthodontic bracket toolA hand-held dental instrument intended to be used by an orthodontist for opening/closing a self-ligating orthodontic bracket and/or tube. It is made of metal and is in the form of a handle with thin pronged ends designed to release/close the orthodontic appliance clip mechanism; it may also be used to hold the archwire in place to assist manual closing of the clip. This is a reusable device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
062165188
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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06438311708676LMDentalLM-DentalDZN2026-03-23
06438311708683LMDentalLM-DentalDZN2026-03-23
06438311708690LMDentalLM-DentalDZN2026-03-23
06438311708706LMDentalLM-DentalDZN2026-03-23
06438311708713LMDentalLM-DentalDZN2026-03-23
06438311708720LMDentalLM-DentalDZN2026-03-23
06438311708737LMDentalLM-DentalDZN2026-03-23
06438311708744LMDentalLM-DentalDZN2026-03-23
06438311708751LMDentalLM-DentalDZN2026-03-23
06438311708768LMDentalLM-DentalDZN2026-03-23
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00840479203119RELIABOX ANTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
00840479203126RELIABOX POSTERIOR BRACKET HOLDING TWEEZERSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-03-11
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00840479201092COMPOSITE FILLING INSTRUMENTSRELIANCE ORTHODONTIC PRODUCTS INCDZN2026-02-27
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