FDA.reportPublic FDA data

Surgical Guide Resin

Primary DI
00850061175090
Brand
Surgical Guide Resin
Company
FORMLABS OHIO INC.
Model
FLSGAM01
Device description
Surgical Guide Resin for cartridge V2
Published
2024-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
NDPAccessories, Implant, Dental, Endosseous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDPAccessories, Implant, Dental, EndosseousDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850061175090PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850061175090008500611750908500611750900850061175090

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, resinA resin intended to be used in the dental laboratory to manufacture a patient-worn dental prosthesis or appliance (e.g., denture base, occlusal splint/night guard), that either: 1) polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured); or 2) can be shaped by a dental mill [e.g., based on computer-aided design/computer-aided manufacturing (CAD/CAM) technology]. It may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
106744280
Device count
1
Premarket exempt
true
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
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
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
00842092187722PreatPreat CorporationNDP2026-06-08
08056591028154JDentalCare Dental InstrumentsJ DENTAL CARE SRLNDP2026-06-08
00840481133756LOCATORZest Anchors, LLCNDP2026-06-05
07630031778086NAInstitut Straumann AGNDP2026-06-03
07630031778093NAInstitut Straumann AGNDP2026-06-03
07630031778109NAInstitut Straumann AGNDP2026-06-03
07630031778116NAInstitut Straumann AGNDP2026-06-03
07630031778123NAInstitut Straumann AGNDP2026-06-03
07630031778130NAInstitut Straumann AGNDP2026-06-03
07630031778147NAInstitut Straumann AGNDP2026-06-03
07630031778154NAInstitut Straumann AGNDP2026-06-03
07630031778161NAInstitut Straumann AGNDP2026-06-03
07630031778192NAInstitut Straumann AGNDP2026-06-03
07630031778208NAInstitut Straumann AGNDP2026-06-03
07630031778215NAInstitut Straumann AGNDP2026-06-03
07630031778222NAInstitut Straumann AGNDP2026-06-03
07630031778239NAInstitut Straumann AGNDP2026-06-03
07630031778260NAInstitut Straumann AGNDP2026-06-03
07630031778277NAInstitut Straumann AGNDP2026-06-03
07630031778284NAInstitut Straumann AGNDP2026-06-03
07630031778291NAInstitut Straumann AGNDP2026-06-03
07630031778307NAInstitut Straumann AGNDP2026-06-03
07630031778338NAInstitut Straumann AGNDP2026-06-03
07630031778345NAInstitut Straumann AGNDP2026-06-03
07630031778352NAInstitut Straumann AGNDP2026-06-03
07630031778369NAInstitut Straumann AGNDP2026-06-03
07630031778376NAInstitut Straumann AGNDP2026-06-03
07630031778406NAInstitut Straumann AGNDP2026-06-03
07630031778413NAInstitut Straumann AGNDP2026-06-03
07630031778420NAInstitut Straumann AGNDP2026-06-03