FDA.reportPublic FDA data

Surgical Guide

Primary DI
00860002099309
Brand
Surgical Guide
Company
FORMLABS OHIO INC.
Model
FLSGAM01
Catalog number
FLSGAM01
Device description
Surgical Guide Resin
Published
2019-11-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
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
00860002099316PackageGS18In Commercial Distribution
00860002099309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860002099316008600020993168600020993160860002099316
00860002099309008600020993098600020993090860002099309

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
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
00850061175090Surgical Guide Resin FLSGAM012024-04-24
00850061175106Dental LT Comfort ResinFLDLCO112024-04-24
00860002099330Dental LT Clear Resin V2FLDLCL02FLDLCL022020-07-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00844868052470T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052487T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052494T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052500T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052517T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052524T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052531T3® PROZimVie US Corp LLCNDP2026-05-28
00844868052548T3® ShortZimVie US Corp LLCNDP2026-05-28
06947600329107Driver,BLT,Adapter,for handpiece,for tap,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329572Driver,BL/BLT,Adapter,for handpiece,L25mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329909Driver,BL/BLT,NoMount Driver,NC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600329923Driver,BL/BLT,NoMount Driver,RC,short,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330691Tap,BLT,Φ3.3mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330707Tap,BLT,Φ4.1mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330714Tap,BLT,Φ4.8mm,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330721Template Fixation Pin,Φ1.35mmBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330738Driver,NoMount Torque Driver,NC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
06947600330745Driver,NoMount Torque Driver,RC,Middle,GuidedBIO CONCEPT Co., Ltd.NDP2026-05-27
08059224214320OT EQUATORRHEIN 83 SRLNDP2026-05-27
08059224214344OT EQUATORRHEIN 83 SRLNDP2026-05-27
08435389830160SHORT POSITIONER FOR UNIVERSAL PLUS PLATFORM (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830177UNIVERSAL PLUS PLATFORM POSITIONER (2 UNITS)BIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
08435389830443SURGICAL GUIDE TEMPORARY BALL ATTACHMENT; MULTI-IM; Ø4,1 mmBIOTECHNOLOGY INSTITUTE SLNDP2026-05-27
EMKA013529MEDENTiKAMEDENTiKA GmbHNDP2020-04-30
EMKA005039MEDENTiKAMEDENTiKA GmbHNDP2020-04-08
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