FDA.reportPublic FDA data

Lucid-Lok™

Primary DI
00817645020108
Brand
Lucid-Lok™
Company
Six Month Smiles
Model
20308
Catalog number
20308
Device description
Lucid-Lok™ UR3 Cuspid .022 Composite Bracket w/Hook
Published
2016-09-24
Public version status
Update
Distribution status
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00817645020108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00817645020108008176450201088176450201080817645020108

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
118919669
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817645020191Porcelain Conditioner901R2021-02-08
00817645020184Assure Plus908R2021-02-05
008176450201776MS Aligners800-ALN2019-07-17
00817645020207Indirect Bonding Tray700D2023-03-16
00817645020009OrthoFlow®904R904R2016-09-24
00817645020016OrthoMax®905R905R2016-09-24
00817645020023Lucid-Lok™20320-120320-12016-09-24
00817645020030Lucid-Lok™20301203012016-09-24
00817645020047Lucid-Lok™20302203022016-09-24
00817645020054Lucid-Lok™20303203032016-09-24
00817645020061Lucid-Lok™20304203042016-09-24
00817645020078Lucid-Lok™20305203052016-09-24
00817645020085Lucid-Lok™20306203062016-09-24
00817645020092Lucid-Lok™20307203072016-09-24
00817645020115Lucid-Lok™20311203112016-09-24
00817645020122Lucid-Lok™20312203122016-09-24
00817645020139Lucid-Lok™20313203132016-09-24
00817645020146Lucid-Lok™20321203212016-09-24
00817645020160OrthoMax®906R06R2018-07-30

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D82944S01720300051Premium LineEC Certification Service GmbHDYW2026-07-31
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D82944S01820300051Premium LineEC Certification Service GmbHDYW2026-07-31
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D82944S01820300501Premium LineEC Certification Service GmbHDYW2026-07-31
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D82944S02020300051Premium LineEC Certification Service GmbHDYW2026-07-31
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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
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D82944S01520300051Premium LineEC Certification Service GmbHDYW2026-07-30
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D829480001C1Premium LineEC Certification Service GmbHDYW2026-07-30
D829480002C1Premium LineEC Certification Service GmbHDYW2026-07-30
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D82948001500000051Premium LineEC Certification Service GmbHDYW2026-07-30
D82948001500000101Premium LineEC Certification Service GmbHDYW2026-07-30