FDA.reportPublic FDA data

Oliv Aligner

Primary DI
00850004223376
Brand
Oliv Aligner
Company
CANDID CARE CO.
Model
FGS-3002
Device description
Oliv Aligner system
Published
2025-11-06
Public version status
New
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
NXCAligner, Sequential

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NXCAligner, SequentialDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190948000Magic Clear AlignersVoodoo Manufacturing, Inc.2019-05-09NXC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850004223376PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850004223376008500042233768500042233760850004223376

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
108729170
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850004223321PermaForm RetainerFGS-00032025-11-06
00850004223789Candid Impression KitFGS-00092021-04-26
00850004223222Candid AlignerFA-00032020-08-28
00850004223079Candid Redo Impression KitRDLGORANGE000012019-03-01
00850004223031Candid Redo Impression KitURBD00032019-03-01
08500042230004Candid AlignerFA-00012020-10-02
00850004223345Candid Impression KitFGS-00102021-10-07
00850004223567Candid AlignerFA-00012021-05-03
00850004223987Candid Refinement Impression KitITISK000012021-03-31
00850004223024Candid Impression KitIKHELLO000012020-07-20
00850004223130Candid Redo Impression KitRDKETTS00012019-10-04
00850004223147Candid Redo Impression KitRDKETTM00012019-10-04
00850004223154Candid Redo Impression KitRDKETTL00012019-10-04
00850004223161Candid Impression KitIKDIGITAL000032019-10-04
00850004223178Candid Impression KitIKMIXFINISHED000012019-10-04
00850004223000Candid Impression KitIKDIGITAL000052020-04-03
00850004223116Candid Impression KitIKMESHFINISHED000022019-10-29
00850004223185Candid Impression KitIKDIGITAL000042019-10-29
00850004223123Candid Impression KitIKDIGITAL000022019-07-09
00850004223109Candid Impression KitIKMESHFINISHED000012019-06-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00856379007313SureSmile®ORAMETRIX, INC.NXC2026-05-20
06956748704394LUMOSCOWuxi EA Medical Instruments Technologies Limited.NXC2026-05-12
D77595102Smart Moves Complete Phase 1 TraysGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775AASS0Super Spring AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ABLR0Bloore Removable AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775AII0Invisible Inman AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ALIA0Lower Inman AlignerGreat Lakes Dental Technologies, Ltd.NXC2026-05-07
D775ALIAW0Lower Inman Aligner 'Wireless' Great Lakes Dental Technologies, Ltd.NXC2026-05-07
06956748700198Angel AlignerWuxi EA Medical Instruments Technologies Limited.NXC2026-05-06
00197998216398Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216428Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216435Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216480Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216527Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216534Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216572Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216596Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216657Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216664Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998216671Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998382772Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00197998382796Clarity™Solventum Orthodontics CorporationNXC2026-04-25
00860015708106SunClear AlignersSun Dental Laboratories, LLCNXC2026-04-16
00860015708113CoastClear AlignersSun Dental Laboratories, LLCNXC2026-04-16
D769CMALIGN0Clear MovesPARK DENTAL RESEARCH CORPNXC2026-04-15
D769CMRETAIN0Clear MovesPARK DENTAL RESEARCH CORPNXC2026-04-15
D769WLALIGN0White LabelPARK DENTAL RESEARCH CORPNXC2026-04-15
D769WLRETAIN0White LabelPARK DENTAL RESEARCH CORPNXC2026-04-15
D769ORCALIGN0Orchestrate 3DPARK DENTAL RESEARCH CORPNXC2026-04-14
D769ORCRETAIN0Orchestrate 3DPARK DENTAL RESEARCH CORPNXC2026-04-14