FDA.reportPublic FDA data

Dental wedge, single-use

Definition
A dental device that is positioned wedge-like at the interdental and cervical area of the teeth during routine intraoral dental procedures. It is used to slightly separate the teeth during the placement of a filling material, or to stabilize and support other devices, e.g., a matrix band or a rubber dam. This is a single-use device.
GUDID devices
271
Last updated
2023-09-20 13:56:36

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
D9498120013Diamond Wedge KitBioclear Matrix SystemsOriginal2023-09-11
D9498120042Diamond Wedge KitBioclear Matrix SystemsOriginal Assorted 8ct2023-09-11
D9491120110Bioclear Diamond WedgeBioclear Matrix SystemsSmall2023-09-10
D9498120012Diamond Wedge KitBioclear Matrix SystemsOriginal2023-09-10
D9498120072Diamond Wedge KitBioclear Matrix SystemsLong2023-09-10
00810135270007FirstChoiceXLENT GLOBAL INCFST-37112023-08-28
00810135270083FirstChoiceXLENT GLOBAL INCFST-37122023-08-28
00810135270090FirstChoiceXLENT GLOBAL INCFST-37132023-08-28
00810135270106FirstChoiceXLENT GLOBAL INCFST-37142023-08-28
00810135270113FirstChoiceXLENT GLOBAL INCFST-37182023-08-28
E2995001PLUS9wood wedgesPolydentia SA5001PLUS2023-08-23
E2995001S9wood wedgesPolydentia SA5001s2023-08-23
E2995011PLUS9pinky wood wedgesPolydentia SA5011PLUS2023-08-23
E2995012PLUS9wood wedgesPolydentia SA5012PLUS2023-08-23
E2995013PLUS9wood wedgesPolydentia SA5013PLUS2023-08-23
E2995015PLUS9wood wedgesPolydentia SA5015PLUS2023-08-23
E2995017PLUS9wood wedgesPolydentia SA5017PLUS2023-08-23
D9491120610Diamond WedgeBioclear Matrix SystemsLong Small2023-09-10
D9491120710Diamond WedgeBioclear Matrix SystemsLong Medium2023-09-10
D9491120810Diamond WedgeBioclear Matrix SystemsLong Large2023-09-10
D9491120910Diamond WedgeBioclear Matrix SystemsLong Extra Large2023-09-10
D9491121010Diamond WedgeBioclear Matrix SystemsLong Furcal2023-09-10
D949112011501Bioclear Diamond WedgeBioclear Matrix SystemsSmall2023-08-07
D9491120210Bioclear Diamond WedgeBioclear Matrix SystemsMedium2023-09-10
D9491120310Bioclear Diamond WedgeBioclear Matrix SystemsLarge2023-09-10
D9491120410Bioclear Diamond WedgeBioclear Matrix SystemsExtra Large2023-09-10
D9491120510Bioclear Diamond WedgeBioclear Matrix SystemsDeep Caries2023-09-10
D9092700211rotation wedgesOrtho Arch Company Inc270-0212023-06-13
D90927002210ROTATION WEDGESOrtho Arch Company Inc270-0222023-06-13
D90927002412SLB ROTATION WEDGESOrtho Arch Company Inc270-0242023-06-13
D2489385209Uni-Wedge Regular Orange (250)HAGER WORLDWIDE, INC.838522023-05-15
D248938540Uni-Wedge, Narrow, Green (250)HAGER WORLDWIDE, INC.938542023-05-15
EMICEMWW1Ena MatrixMICERIUM SPAEMWW2023-05-03
00810038090832Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.SGK42023-02-14
00810038090849Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.SGK4-M2023-02-14
00810038090580Strata-G™GARRISON DENTAL SOLUTIONS, L.L.C.SGYL-M2023-02-14
00810038090597Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.SGBL-M2023-02-14
00810038090603Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.SGOR-M2023-02-14
00810038090610Strata-G™ GARRISON DENTAL SOLUTIONS, L.L.C.SGGR-M2023-02-14
17310236026799FenderWedge & FenderMate Directa ABIntro-Kit2022-12-07
17310236027499FenderWedge Directa ABPrep2022-12-07
17310236027505FenderWedge Directa ABAssortment2022-12-07
17310236027512FenderWedgeDirecta ABSmall2022-12-07
17310236027529FenderWedge Directa ABMedium2022-12-07
17310236027536FenderWedge Directa ABLarge2022-12-07
17310236027543FenderWedge Directa ABX-small2022-12-07
17310236027703FenderMate Directa ABAssortment2022-12-07
17310236027710FenderMateDirecta ABLeft Regular2022-12-07
17310236027727FenderMate Directa ABLeft Narrow2022-12-07
17310236027734FenderMate Directa ABRight Regular2022-12-07
17310236027741FenderMate Directa ABRight Narrow2022-12-07
17310236027864FenderMate Directa ABTemp2022-12-07
17310236028007FenderWedge Directa ABValue Pack2022-12-07
17310236028014FenderWedge Directa ABValue Pack2022-12-07
17310236028021FenderWedge Directa ABValue Pack2022-12-07
17310236028038FenderWedge Directa ABValue Pack2022-12-07
17310236028045FenderMate Directa ABValue Pack, Left Regular2022-12-07
17310236028052FenderMate Directa ABValue Pack, Left Narrow2022-12-07
17310236028069FenderMate Directa ABValue Pack, Right Regular2022-12-07
17310236028076FenderMate Directa ABValue Pack, Right Narrow2022-12-07
17310236028083FenderMate Directa ABPrime Value Pack, Short2022-12-07
17310236028090FenderMate Directa ABValue Pack, Long2022-12-07
17310236028113FenderWedge Directa ABPrep Value Pack2022-12-07
17310236028137FenderMate Directa ABTemp Value Pack2022-12-07
17310236028151FenderMate Directa ABPrime Assortment2022-12-07
17310236028168FenderMate Directa ABPrime Short2022-12-07
17310236028175FenderMate Directa ABPrime Long2022-12-07
17310236029905FenderMateDirecta ABD-coat Left Regular2022-12-07
17310236029912FenderMate Directa ABD-coat Left Narrow2022-12-07
17310236029929FenderMate Directa ABD-coat Right Regular2022-12-07
17310236029936FenderMate Directa ABD-coat Right Narrow2022-12-07
17310236029943FenderMate Directa ABD-coat Assortment2022-12-07
17310236027352FenderWedge Directa ABNG Purple2022-12-06
17310236027369FenderWedgeDirecta ABNG Orange2022-12-06
H66809214170BosworthKeystone Industries09214172022-11-30
H66809214180BosworthKeystone Industries09214182022-11-30
H66809214190BosworthKeystone Industries09214192022-11-30
H66809214200BosworthKeystone Industries09214202022-11-30
H66809214210BosworthKeystone Industries09214212022-11-30
H66809214220BosworthKeystone Industries09214222022-11-30