FDA.reportPublic FDA data

SunClear Aligners

Primary DI
00860015708106
Brand
SunClear Aligners
Company
Sun Dental Laboratories, LLC
Model
SunClear Aligners
Published
2026-04-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DYWBracket, Plastic, Orthodontic
NXCAligner, Sequential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYWBracket, Plastic, OrthodonticDental2
NXCAligner, SequentialDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190394000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190394000SunClear Aligner systemSun Dental Laboratories, LLC2019-12-16NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860015708106PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860015708106008600157081068600157081060860015708106

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic progressive alignerA custom-made orthodontic appliance, typically supplied in series intended to be worn in succession and self-changed every few weeks, designed to influence the shape and/or function of the stomatognathic system to correct malocclusions (e.g., underbites, overbites, cross bites, open bites, crooked teeth) and/or other cosmetic and/or structural flaws of teeth and/or jaws. Also described as sequential or successive, the device is custom-made based on an oral impression, self-removable, and is typically made of clear/transparent synthetic polymers (e.g., a thermoformed polycarbonate); a post-treatment orthodontic retainer/positioner may be included with the device. This is a reusable device.

Regulatory Flags#

DUNS number
165410940
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860015708113CoastClear AlignersCoastClear Aligners2026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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D82966101820000101Premium LineEC Certification Service GmbHDYW2026-06-09
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D829661018200M0101Premium LineEC Certification Service GmbHDYW2026-06-09
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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