Surgical devices · 21 CFR 872 Subpart E

Dental Wax Carver

FDA device type “Carver, Wax, Dental”.

FDA codeEIKClass121 CFR872.4565Pathway510(k) exemptCategoryDental hand instruments
Companies listing it
9883 makers
Brands and models
126
510(k) clearances
50 in five years
FDA name
Carver, Wax, Dental
1985: 11986: 11990: 11998: 12002: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EIK

98 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Premier Dental Products CompanyUnited StatesMakerPREMIER WAX CARVER282026
Medicon EGGermanyMaker—92005
Integra LifeSciences CorporationUnited StatesMakerIntegra · Jarit · Miltex · Padgett · +222014
Storz AM Mark GmbHGermanyMakerWax instrument22008
Hager Worldwide, Inc.United StatesMakerAlmore Electra Waxer · Almore Mini Waxer · Almore Soft Lining Trimmer · Hager Wax Carving Set22005
Arnold Tuber IndustriesUnited StatesMakerCarver12009
Osung Mnd Co LtdSouth KoreaMakerL-PKT · LCPKT1 · LCPKT2 · LCPKT3 · +2——
Zain's Medical ImagePakistanMakerWAX CARVER——
Schobell Industrial LtdaBrazilMakerSpatula Lecron——
Shanghai Kangqiao Dental Instruments FactoryChinaMakerCarver For Silicone R1 · Carver For Silicone R2 · P.K.Thomas carver KWC PKT1/PKT2/PKT3/PKT4/PKT5 · Wax carver KWC 5/6/7/8/9/10/11/12/C1/C2/C3/C4/C5/C6 · +4——
株式会社YDMJapanMakerPorcelain & Wax Carver Evan——
B. Ali ImpexPakistanMakerBALI · DOCTOR NICE · HOLLANBACK · , Cleoid Discoid——
Bashir Jamil & Bros. (Pvt.), Ltd.PakistanMakerA7 COMFORT GRIP WAX INSTR · B7 COMFORT GRIP WAX INSTR · DOZ NO 24 CEMENT SPETULA · DOZ NO 7 WAX SPETULA · +12——
Technimen SkillersPakistanMakerDental Carver, Ward Carver, Wall Carver, Hollenback Carver,——
Cislak Manufacturing, Inc.United StatesMakerCislak · Zoll Dental——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerDental Carver——
Pomee CorporationPakistanMakerHollenback # 2——
Commic SurgicoPakistanMakerCARVER, WAX, DENTAL——
Medcave Private LimitedPakistanMakerWax Carver——
Nordent MFG., Inc.United StatesMakerNordent Lab Carvers——
Panorama InternationalPakistanMakerCARVER, WAX, DENTAL——
Accompany SurgicalPakistanMakerDENTAL CARVERS——
Lacigrus InternationalPakistanMakerCARVER, WAX, DENTAL——
Pascal InternationalUnited StatesMakerGet Sculpted Wax Carving Set——
Aesculap AGGermanyMakerAesculap——
PDT Inc.United StatesMakerPDT, Inc.——
Adolf Schweick Hardt GmbH & CoGermanyMakerCARVING INSTRUMENTS——
Confident InstrumentsPakistanMakerArtman Instruments——
Denta Craft InstrumentsPakistanMakerDENTAL CARVERS——
Medisporex Private LimitedPakistanMakerMEDIS——
Dentag SRLItalyMakerDENTAG——
Garish ApparelsPakistanMakerTamzon Instruments Inc.——
Acme EnterprisesPakistanMakerTBS Dental——
SurgicraftsPakistanMakerEIK / CARVER, WAX, DENTAL——
Acheron Instruments (Pvt.) Ltd.PakistanMakerWax Knives——
Silver Plus Corp.PakistanMakerCARVER, WAX, DENTAL——
Shanghai Medical Instruments (Group) Ltd. Corp.ChinaMakerWAX CARVER——
SurgiscapePakistanMakerCARVER, WAX, DENTAL——
Towne Brothers (Pvt) LtdPakistanMakerEIK - CARVER, WAX, DENTAL——
Choose Surgical InstrumentsPakistanMakerCARVER, WAX, DENTAL——
Lohar Medical CompanyPakistanMakerEIK / CARVER, WAX, DENTAL——
Mident LtdUnited KingdomMakerWax Carver——
Nadir & Co.PakistanMakerFahnenstock Wax Knife——
Y. Z. CorporationPakistanMakerYZ Dental Wax Carver——
Daddy D ProPakistanMakerCarver Wax Dental——
Crown Surgical Corp.PakistanMakerCROWN ECO——
Nopa Instruments Medizintechnik GmbHGermanyMakerCARVER——
SurjexPakistanMakerCARVER, WAX, DENTAL——
Dimeda Instrumente GmbHGermanyMakerDIMEDA——
B. Braun Medical Industries Sdn. BhdMalaysiaMakerAesculap——
Medesy SrlItalyMakerFAHNENSTOCK——
Mian Shahid Corp.PakistanMakerCARVER, WAX, DENTAL——
Spartech Instruments & Co.PakistanMakerCARVER——
Med2B Ltd.GermanyMakerCARVER, WAX, DENTAL——
Melpex Beauty InstrumentsPakistanMakerCARVER, WAX, DENTAL——
Armatech InternationalPakistanMakerCARVER, WAX, DENTAL——
Central Surgical Co. Pvt. Ltd.PakistanMakerCARVER, WAX, DENTAL, CARVERS OF ALL TYPES——
Sabokay IndustriesPakistanMakerCarver, Wax, Dental——
Darleys Surgical Co.PakistanMakerCARVER, WAX, DENTAL——
Elite Dental LabChinaMakerWax Carver——
Hazel EnterprisesPakistanMakerELEVATOR, SURGICAL, DENTAL——
SurgikarePakistanMakerCARVER, WAX, DENTAL——
T.A. Walthem & CompanyPakistanMakerCARVER, WAX, DENTAL——
Washington Surgical InternationalPakistanMakerCARVER, WAX, DENTAL——
Hebu Medical GmbHGermanyMakerCarver, Wax, Dental——
Infirmary Medical SuppliesPakistanMakerCARVER, WAX, DENTAL——
Madina Surgical WorksPakistanMakerCARVER, WAX, DENTAL——
Alvi ExpoPakistanMakerCARVER, WAX, DENTAL——
Richbolt EnterprisesPakistanMakerRICHBOLT ENTERPRISES——
Laparomed Private LimitedIndiaMakerWAX AND MATERIAL KNIVES——
Concise EnterprisesPakistanMakerCarver and Dental Amalgam——
Peter Brasseler Holdings, LLCUnited StatesMaker———
Glorious Mercantile Corp. (Pvt.) Ltd.PakistanMakerDEVICE——
Empire Surgical Instruments CompanyPakistanMakerEMPSURG——
J&J InstrumentsUnited StatesMaker———
Zentro Enterprise Pvt. Ltd.IndiaMakerCARVER, WAX, DENTAL——
Kohler Medizintechnik GmbHGermanyMaker———
Hermann Mueller Medizintechnik GmbHGermanyMaker———
Phoenix Instruments, Inc.United StatesMaker———
USTOMED INSTRUMENTE GmbH & Co. KGGermanyMaker———
Xinhua Surgical Instrument Co.,Ltd.ChinaMaker———
Gulmag InternationalPakistanMaker———
Helmut Zepf Medizintechnik GmbHGermanyMaker———
Pulpdent CorporationUnited StatesManufacturerLAB CARVER1072021
Buffalo Dental Mfg. Co., Inc.United StatesManufacturerDENTAL WAX CARVER111996
Aesculap, Inc.United StatesListerAesculap22006
George Taub Products & Fusion Co., Inc.United StatesManufacturerWAX CARVER SET21986
A. Titan Instruments, Inc.United StatesContract manufacturerCarver12006
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerBESQUAL——
Patterson Companies, Inc.United StatesForeign exporterCARVER, WAX, DENTAL——
Aspen Surgical ProductsUnited StatesContract manufacturerSymmetry Surgical——
TBS DentalUnited StatesRepacker / relabelerTBS INOX USA——
Wise Linkers LLCUnited StatesRepacker / relabelerArtman Instruments——
Sklar CorporationUnited StatesRepacker / relabelerCarver——
YCH Distripark Sdn BhdMalaysiaForeign exporterAesculap——
E A Beck & CompanyUnited StatesRepacker / relabelerCARVER, WAX, DENTAL——
Bird-X, Inc.United StatesManufacturerWaxiron——
Novo Surgical Inc.United StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
22 Feb 2002K013993NEOCALEXStephen M Koral, Dmd
26 Jan 1998K972642PERIO CONTROL IIEstrad B.V.
13 Sep 1990K902653PDS-2000Intl. Equipment and Supply Corp.
17 Mar 1986K860817ROOT CANAL ORGANIZERPacific Union Dental, Inc.
2 Jul 1985K8517272020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAArtiberia

Official records: FDA product classification for EIK · 21 CFR 872.4565.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026