FDA.reportPublic FDA data

Dental LT Clear Resin V2

Primary DI
10860002099337
Brand
Dental LT Clear Resin V2
Company
FORMLABS OHIO INC.
Model
FLDLCL02
Catalog number
FLDLCL02
Published
2020-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
KMYPositioner, Tooth, Preformed

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KMYPositioner, Tooth, PreformedDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10860002099337PackageGS18In Commercial Distribution
00860002099330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1086000209933710860002099337
00860002099330008600020993308600020993300860002099330

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature50 Degrees Fahrenheit77 Degrees Fahrenheit
Special Storage Condition, Specify00Keep out of sunlight

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106744280
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
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
00850061175007Premium Teeth Resin FLPTBL012024-04-24
00850061175014Premium Teeth Resin FLPTA2012024-04-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800142101007Tera TainerGraphy Inc.KMY2026-05-14
H66842000141KeyPrintKeystone IndustriesKMY2024-09-26
H66841101411KeyPrintKeystone IndustriesKMY2023-09-25
H66842201511KeyPrintKeystone IndustriesKMY2023-09-25
08719425509549Vertex-Dental BVVertex-Dental B.V.KMY2023-06-20
08719425509556NextDentVertex-Dental B.V.KMY2023-06-15
H66842000111KeyPrintKeystone IndustriesKMY2023-02-20
H66842001611KeyPrintKeystone IndustriesKMY2023-02-20
H66842200111KeyPrintKeystone IndustriesKMY2023-02-20
H66842201141HeyGearsKeystone IndustriesKMY2023-02-20
EPRCD1001609PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001610PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
EPRCD1001611PRO3DURE GR-19 OApro3dure medical GmbHKMY2022-12-06
H668210241American DentalKeystone IndustriesKMY2022-11-30
H668210251American DentalKeystone IndustriesKMY2022-11-30
H668210261American DentalKeystone IndustriesKMY2022-11-30
H668210271American DentalKeystone IndustriesKMY2022-11-30
H668210341American DentalKeystone IndustriesKMY2022-11-30
EPRCD1001703PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRCD1001704PRO3DURE GR-22 flex pro3dure medical GmbHKMY2022-02-14
EPRC66077916dima Print Splint clear pro3dure medical GmbHKMY2021-11-25
EPRCD1000800PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1000801PRO3DURE GR-10 guidepro3dure medical GmbHKMY2021-10-29
EPRCD1001491PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001492PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001493PRO3DURE GR-19 OApro3dure medical GmbHKMY2021-10-29
EPRCD1001701PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
EPRCD1001702PRO3DURE GR-22 flex pro3dure medical GmbHKMY2021-10-29
ERKO5142052ErkolenErkodent Erich Kopp GmbHKMY2021-09-21
ERKO5142072ErkolenErkodent Erich Kopp GmbHKMY2021-09-21