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Found 9 results
510(k) Data Aggregation
K Number
K234043Device Name
3M Transbond Orthodontic Adhesive
Manufacturer
3M Unitek Orthodontic Products
Date Cleared
2023-12-22
(1 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
3M Unitek Orthodontic Products
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3M Transbond Orthodontic Adhesive is indicated for the following uses:
- · Creating attachments for orthodontic tray aliqners.
- · Bonding orthodontic brackets to teeth.
Device Description
3M Transbond Orthodontic Adhesive is a thixotropic, visible-light activated, radiopaque orthodontic adhesive. The product is stored in a multi-use syringe which is used with single-use dispensing tips.
3M Transbond Orthodontic Adhesive contains bisGMA, TEGDMA and Procrylat resins. The fillers are a combination of ytterbium trifluoride filler with a range of particles sizes from 0.1 to 5.0 microns, a non-agglomerated/non-aggregated surface modified 20 nm silica filler, a non-agglomerated/non-aggregated surface modified 75 nm silica filler, and a surface modified aggregated zirconia/silica cluster filler (comprised of 20 nm silica and 4 to 11 nm zirconia particles). The aggregate has an average cluster particle size of 0.6 to 10 microns. The inorganic filler loading is approximately 65% by weight (46% by volume).
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K Number
K163689Device Name
3M Clear Tray Aligner
Manufacturer
3M Unitek Corporation
Date Cleared
2017-01-27
(30 days)
Product Code
NXC
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
3M Unitek Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 3MM Clear Tray Aligner system is a series of clear, lightweight, plastic appliances indicated for the treatment of tooth malocclusions in patients with permanent dentition (i.e., all second molars). Utilizing a series of incremental tooth movements, it sequentially positions teeth by way of continuous gentle force.
Device Description
The 3M Clear Tray Aligner System is a series of clear plastic aligners that offer a solution for patients who want an aesthetic orthodontic treatment by utilizing a set of removable aligners to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology.
A dental health professional (e.g. orthodontist or dentist), using a standard personal computer prescribes the 3M Clear Tray Aligner system based on an assessment of the patient's teeth, determines a course of treatment with the system, takes molds of the patient's teeth and completes a prescription form using a standard dental software used for tooth alignment, 3M then designs a series of plastic travs intended to gradually realign the patient's teeth in accordance with the physician's prescription using a standard dental software used for tooth alignment. The prescribing physician reviews and approves the model scheme before the molds are produced. Once approved, 3M produces trays, which are formed of clear, thin, thermoformed plastic. The trays are sent back to the dental health care professional who then provides them to the patient, confirming fit and design. Over a period, additional trays are provided sequentially to the patient by the dental health professional to gradually move the target teeth to the designed position. The dental care professional monitors treatment from the moment the first aligner is delivered to when the final aligner is delivered. The trays are held in place by pressure and can be removed by the patient at any time.
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K Number
K113197Device Name
APC FLASH-FREE ADHESIVE
Manufacturer
3M UNITEK CORPORATION
Date Cleared
2012-02-02
(94 days)
Product Code
DYH, EJF, NJM
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
3M UNITEK CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
APC™ Flash-Free Adhesive is indicated for use in bonding orthodontic appliances for orthodontic treatment.
Device Description
It consists of a resin-saturated mat that is attached to the apprimated for Craceets, ceramic brackets, and bondable buccal tubes. The relatively low viscosity of the resin allows it to form a fillet at the edges of the bracket which reduces the need to remove excess adhesive, also known as flash.
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K Number
K102803Device Name
CLARITY ADVANCED CERAMIC BRACKETS
Manufacturer
3M UNITEK CORPORATION
Date Cleared
2011-02-17
(142 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
3M UNITEK CORPORATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clarity™ Advanced Ceramic Brackets are intended for use in orthodontic treatment. The brackets are affixed to teeth so that pressure can be exerted on the teeth.
Device Description
Clarity Advanced Ceramic Brackets are intended to teeth, upon which an orthodontic wire is used to move the teeth to new positions. Clarity Advanced Ceramic Brackets consist of a translucent alumina body and a glass-grit bonding base. The bracket is either uncoated or coated with a thin film of stabilized zirconia. The brackets incorporate a watersoluble color placement indicator system that marks archwire and vertical slots to aid in bracket positioning and color codes tie wing(s) to facilitate bracket identification.
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K Number
K100536Device Name
TRANSBOND IDB PRE-MIX CHEMICAL CARE ADHESIVE
Manufacturer
3M UNITEK
Date Cleared
2010-07-27
(152 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
3M UNITEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K073697Device Name
TRANSBOND SUPREME ADHESIVE
Manufacturer
3M UNITEK
Date Cleared
2008-02-15
(46 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
3M UNITEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K062305Device Name
CLARITY MODIFIED CERAMIC BRACKETS
Manufacturer
3M UNITEK
Date Cleared
2006-10-18
(71 days)
Product Code
NJM
Regulation Number
872.5470Why did this record match?
Applicant Name (Manufacturer) :
3M UNITEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Clarity Modified Ceramic Bracket is intended for use in orthodontic treatment.
Device Description
Not Found
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K Number
K020394Device Name
APC PLUS ADHESIVE
Manufacturer
3M UNITEK
Date Cleared
2002-04-12
(65 days)
Product Code
DYH, DYW, EJF
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
3M UNITEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
3M™ Unitek™ APC™ Plus Adhesive is indicated for use in orthodontic appliance application and bonding for orthodontic treatment.
Device Description
Not Found
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K Number
K014142Device Name
UNITE BONDING ADHESIVE
Manufacturer
3M UNITEK
Date Cleared
2002-02-28
(73 days)
Product Code
DYH
Regulation Number
872.3750Why did this record match?
Applicant Name (Manufacturer) :
3M UNITEK
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Unite Bonding Adhesive is indicated for bonding orthodontic appliances to teeth for orthodontic treatment.
Device Description
Not Found
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