FDA.reportPublic FDA data

OrthoFit Aligner

Primary DI
08809262957082
Brand
OrthoFit Aligner
Company
Spident Co., Ltd.
Model
OrthoFit Aligner A2 * 4ea
Catalog number
#3809P04
Device description
OrthoFit Aligner is an orthodontic light-cured composite resin for aligner attachments. OrthoFit Aligner is used with etchants and dentin bonding agents. The inorganic fillers in OrthoFit Aligner have a particle size range of 0.01 to 0.5 um and consist of approximately 46% by volume.
Published
2026-10-29
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

Product Codes#

Code, Name table
CodeName
DYHAdhesive, Bracket And Tooth Conditioner, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYHAdhesive, Bracket And Tooth Conditioner, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K262433000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K262433000OrthoFit Aligner (OrthoFit Aligner A2)Spident Co., Ltd.2026-10-13DYH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08809262957082PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08809262957082088092629570828809262957082

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.

Regulatory Flags#

DUNS number
689370711
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08809262957068OrthoFit AlignerOrthoFit Aligner A2 * 2ea#3809P022026-10-29
08809262957075OrthoFit AlignerOrthoFit Aligner A2 * 1ea#3809P012026-10-29
08809262955514FineDamFineDam x 4ea2026-10-07
08809262954302Soft Prep101-1401101-14012017-02-20
08809262950823OrthoFitOrthoFit Bond mini2026-07-14
08809262957983OrthoFitOrthoFit Bond 2ea2026-07-14
08809262957990OrthoFitOrthoFit Splint2026-07-14
08809262953602EsCemEsCem A22026-04-29
08809262953619EsCemEsCem A32026-04-29
08809262953626EsCemEsCem TW2026-04-29
08809262959000Temro.FlowTemp it Flow+ yellow 4ea2026-04-28
08809262959017Temro.FlowTemp it Flow+ Blu 4ea2026-04-28
08809262953206EsCom250EsCom250 A1#3203A12026-04-21
08809262953213EsCom250EsCom250 A2#3203A22026-04-21
08809262953220EsCom250EsCom250 A3#3203A32026-04-21
08809262953237EsCom250EsCom250 A3.5#3203A352026-04-21
08809262953244EsCom250EsCom250 A4#3203A42026-04-21
08809262953251EsCom250EsCom250 B1#3203B12026-04-21
08809262953268EsCom250EsCom250 B2#3203B22026-04-21
08809262953275EsCom250EsCom250 C2#3203C22026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08809262957068OrthoFit AlignerSpident Co., Ltd.DYH2026-10-29
08809262957075OrthoFit AlignerSpident Co., Ltd.DYH2026-10-29
00197998073557SolventumSolventum Orthodontics CorporationDYH2026-10-25
00197998073564SolventumSolventum Orthodontics CorporationDYH2026-10-25
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00197998063985SolventumSolventum Orthodontics CorporationDYH2026-10-24