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Found 3 results
510(k) Data Aggregation
K Number
K240538Device Name
Premium Teeth Resin
Manufacturer
Formlabs Ohio, Inc.
Date Cleared
2024-07-19
(144 days)
Product Code
EBG, PZY
Regulation Number
872.3770Why did this record match?
Applicant Name (Manufacturer) :
Formlabs Ohio, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Premium Teeth Resin, when utilized to print 3D printed dental appliances such as denture teeth for complete and partial removable dentures, try-in dentures, provisional full arch implant-supported restoration and provisional restorations such as temporary crowns and bridges, inlays, onlays and veneers, is indicated to replace or restore missing tooth structures or missing teeth.
Device Description
Formlabs Premium Teeth Resin is a light-curable polymer-based resin of 3D printed dental appliances, such as denture teeth for complete and partial res, try-in dentures, provisional full arch implant-supported restoration, and provisional restorations including temporary crowns and bridges, inlays, onlays and veneers. Formlabs Premium Teeth Resin is used to fabricate patient-specific dental appliances in a stereolithographic (SLA) 3D printer using layer additive manufacturing.
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K Number
K232087Device Name
Dental LT Comfort Resin
Manufacturer
Formlabs Ohio, Inc.
Date Cleared
2024-02-16
(218 days)
Product Code
MQC, CLA, KMY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Formlabs Ohio, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental LT Comfort Resin when utilized to print dental or orthodontic appliances such as occlusal splints, nightguards, mouthguards and repositioners is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.
Device Description
Dental LT Comfort Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances, such as occlusal splints, nightguards, mouthguards and repositioners by additive manufacturing.
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K Number
K222061Device Name
Dental LT Clear V2 Resin
Manufacturer
Formlabs Ohio, Inc.
Date Cleared
2022-11-10
(120 days)
Product Code
MQC, DYT, KMY
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
Formlabs Ohio, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Dental Clear LT V2 Resin when utilized to print dental or orthodontic appliances such as occlusal splints, night guards, or mouth guards is indicated to treat patients diagnosed with Temporomandibular Joint Disorders (TMD) and/or Bruxism, respectively.
Device Description
Dental LT Clear V2 Resin is a light-curable polymer-based resin designed for the fabrication of biocompatible, long-term use, removable dental and orthodontic appliances by additive manufacturing.
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