FDA.reportPublic FDA data

Premium Teeth Resin

Primary DI
00850061175014
Brand
Premium Teeth Resin
Company
FORMLABS OHIO INC.
Model
FLPTA201
Device description
Premium Teeth Resin (HT A2) for cartridge v2
Published
2024-04-24
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
PZYAdditively Manufactured, Preformed, Resin Denture Tooth

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PZYAdditively Manufactured, Preformed, Resin Denture ToothDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240538000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240538000Premium Teeth ResinFormlabs Ohio, Inc.2024-07-19EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061175014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061175014008500611750148500611750140850061175014

GMDN Terms#

Term, Definition table
TermDefinition
Resin artificial teethPrefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106744280
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850061175007Premium Teeth Resin FLPTBL012024-04-24
00850061175021Premium Teeth Resin FLPTB1012024-04-24
00850061175038Premium Teeth Resin FLPTA3012024-04-24
00198168761953Premium Teeth ResinFLPTA3012024-02-01
00860002099378Premium Teeth Resin FLPTA2012024-02-01
00860002099385Premium Teeth Resin FLPTB1012024-02-01
00860002099392Premium Teeth Resin FLPTBL012024-02-01
00850061175151H-0600 ResinRS-RPS-H6PR-01 2025-12-01
00850061175113Dental LT Clear V2 ResinFLDLCL022025-10-15
00850061175120Dental LT Comfort ResinFLDLCO012025-10-15
00850061175137Custom Tray ResinFLCTBL012025-10-15
00850061175144Surgical Guide ResinFLSGAM012025-10-15
00850061175168Dental LT Comfort ResinFLDLCO112025-10-15
00850061175069Custom Tray ResinFLCTBL012024-04-24
00850061175076Dental LT Clear V2FLDLCL02 2024-04-24
00850061175083IBT Flex Resin FLIBFL012024-04-24
00850061175090Surgical Guide Resin FLSGAM012024-04-24
00850061175106Dental LT Comfort ResinFLDLCO112024-04-24
00860002099330Dental LT Clear Resin V2FLDLCL02FLDLCL022020-07-07
00860002099354Dental LT Comfort ResinFLDLCO01FLDLCO012023-10-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
D800ZBAC6405A010Printer Resin Denture Tooth Temporary A1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A020Printer Resin Denture Tooth Temporary A2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A030Printer Resin Denture Tooth Temporary A3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A040Printer Resin Denture Tooth Temporary A4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405A350Printer Resin Denture Tooth Temporary A3,5 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B010Printer Resin Denture Tooth Temporary B1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B020Printer Resin Denture Tooth Temporary B2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B030Printer Resin Denture Tooth Temporary B3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405B040Printer Resin Denture Tooth Temporary B4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405BLE0Printer Resin Denture Tooth Temporary Bleach (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C010Printer Resin Denture Tooth Temporary C1 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C020Printer Resin Denture Tooth Temporary C2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C030Printer Resin Denture Tooth Temporary C3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405C040Printer Resin Denture Tooth Temporary C4 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D020Printer Resin Denture Tooth Temporary D2 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D030Printer Resin Denture Tooth Temporary D3 (500g)ZIRKONZAHN SRLPZY2026-05-20
D800ZBAC6405D040Printer Resin Denture Tooth Temporary D4 (500g)ZIRKONZAHN SRLPZY2026-05-20
00810060227053Blue Sky Bio, LLC.BLUE SKY BIO LLCPZY2026-04-13
00810222900022OnX Tough 2 - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00810222900039OnX Tough 2 - Bleach - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544740Crown HT - A1 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544757Crown HT - A2 - Multi-unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544788OnX Tough 2 - A1 - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544795OnX Tough 2 - Bleach - Multi-Unit Capsule 1-PackSprintray, Inc.PZY2026-04-08
00850070544931Crown HT - A1 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
00850070544948Crown HT - A2 - Multi-Unit Capsule 3-PackSprintray, Inc.PZY2026-04-08
08056865154466ACRY NATURE AFG 6 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155647ACRY NATURE AFG 6 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155654ACRY NATURE AFG 8 UPPERDENTAL MANUFACTURING SPAPZY2026-03-17
08056865155661ACRY NATURE AFG 8 LOWERDENTAL MANUFACTURING SPAPZY2026-03-17