Miscellaneous devices · 21 CFR 872 Subpart G

Rubber Dam Clamp

FDA device type “Clamp, Rubber Dam”.

FDA codeEEFClass121 CFR872.6300Pathway510(k) exemptCategoryRubber dam systems
Companies listing it
9474 makers
Brands and models
433
510(k) clearances
30 in five years
FDA name
Clamp, Rubber Dam
1978: 11992: 12007: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list EEF

94 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Sybron Dental SpecialtiesUnited StatesMakerSoftClamp2032026
Kulzer, LLCUnited StatesMakerIVORY RUBBER DAM CLAMP · Ivory Rubber Dam Complete Kit · IVORY RUBBER DAM INTRO KIT · Ivory Rubber Dam Starter Kit372026
Dent4You AGSwitzerlandMakerHySolate Brinker Dental Dam Clamp · HySolate Dental Dam Clamp · HySolate Fiesta Dental Dam Clamp52026
Coltene/Whaledent AGSwitzerlandMakerHygenic® Brinker Clamps · Hygenic® Dental Dam Clamp-Sets · Hygenic® Dental Dam Clamps · Hygenic® Fiesta® Color Coded Matte Finish Clamps · +4452022
Shinhung Company, Ltd.South KoreaMakerK-CLAMP22023
Medicon EGGermanyMaker—92005
Hu-Friedy Mfg Co., LLCUnited StatesMakerHu-Friedy Mfg Co.,LLC82012
Storz AM Mark GmbHGermanyMakerRubber dam clamp22008
Dfl Industria E Comercio SABrazilMakerKS Dent22013
Osung Mnd Co LtdSouth KoreaMakerRDC2 · RDC201 · RDC202 · RDC203 · +8——
TOR VM Ltd.RussiaMakerCat.#0 Clamp · Cat.#0-B Clamp · Cat.#00 Clamp · Cat.#00-B Clamp · +128——
ErgoDenta ApSDenmarkMakerAinsworth Rubber Dam Punch, 17cm · G27 - Molar rubber dam clamps (GENERAL) · G27N - Pre molar rubberdam clamps · Ivory Rubber Dam Clamp Forceps, 17cm · +61——
Zain's Medical ImagePakistanMakerRUBBER DAM CLAMP # 0 · RUBBER DAM CLAMP # 00 · RUBBER DAM CLAMP # 1 · RUBBER DAM CLAMP # 2 · +4——
Densol International (Private) LimitedPakistanMakerRubber Dam Clamp #00 · Rubber Dam Clamp #12A · Rubber Dam Clamp #12A TIT Black · Rubber Dam Clamp #13A · +38——
B. Ali ImpexPakistanMakerAINSWORTH · BALI · DOCTOR NICE · IVERY——
Bashir Jamil & Bros. (Pvt.), Ltd.PakistanMakerRUBBER DAM CLAMP TYPE 0 · RUBBER DAM CLAMP TYPE 00 · RUBBER DAM CLAMP TYPE 1 · RUBBER DAM CLAMP TYPE 12A · +24——
Huanghua Promisee Dental Co., LtdChinaMakerDental Dam Kit · Wedge Floss——
Technimen SkillersPakistanMakerIVORY RUBBER DAM CLAMP——
Falcon Surgical Co. (Pvt.) Ltd.PakistanMakerRubber Dam Clamp——
Medcave Private LimitedPakistanMakerRubber Dam Clamp——
Panorama InternationalPakistanMakerRubber Dam Clamps——
Accompany SurgicalPakistanMakerRubber Dam Clamp——
Lacigrus InternationalPakistanMakerCLAMP, RUBBER DAM——
Comfort Surgical InstrumentsPakistanMakerRubber Dam Clamp——
Aesculap AGGermanyMakerAesculap——
Confident InstrumentsPakistanMakerArtman Instruments——
Tangshan Zhengtong Exhibition Co., Ltd.ChinaMaker———
Denta Craft InstrumentsPakistanMakerRubber Dam Clamp——
Hilbro Instruments (Pvt) LtdPakistanMakerCLAMP, RUBBER DAM · HILBRO INSTRUMENTS RUBBER DAM CLAMP——
Medisporex Private LimitedPakistanMakerCLAMP, RUBBER DAM——
Garish ApparelsPakistanMakerTamzon Instruments Inc.——
Acme EnterprisesPakistanMakerRubber Dam Clamp · TBS Dental——
SurgicraftsPakistanMakerEEF / CLAMP, RUBBER DAM——
Acheron Instruments (Pvt.) Ltd.PakistanMakerRubber Dam Clamp——
Silver Plus Corp.PakistanMakerCLAMP, RUBBER DAM——
SurgiscapePakistanMakerCLAMP, RUBBER DAM——
Towne Brothers (Pvt) LtdPakistanMakerEEF - CLAMP, RUBBER DAM——
Biopsy Fine Cut InstrumentsPakistanMakerCLAMP · CLAMP, RUBBER DAM——
Choose Surgical InstrumentsPakistanMakerCLAMP, RUBBER DAM——
Lohar Medical CompanyPakistanMakerEEF / CLAMP, RUBBER DAM——
Daddy D ProPakistanMakerRubber Dam Clamp——
Crown Surgical Corp.PakistanMakerCROWN ECO——
SurjexPakistanMakerCLAMP, RUBBER DAM——
Dimeda Instrumente GmbHGermanyMakerDIMEDA——
HILBRO International (Pvt) Ltd.PakistanMakerCLAMP, RUBBER DAM——
Medesy SrlItalyMakermedesy——
Meed Skills SurgicalPakistanMakerMeed Skills Surgical——
Mian Shahid Corp.PakistanMakerCLAMP, RUBBER DAM——
Volgo Care International (Private) LimitedPakistanMakerVOLGOCARE——
Dentech Corp.JapanMakerCLAMP, RUBBER DAM——
Spartech Instruments & Co.PakistanMakerCLAMP · RUBBER DAM——
Sabokay IndustriesPakistanMakerClamp, Rubber Dam——
Darleys Surgical Co.PakistanMakerCLAMP, RUBBER DAM——
Elite Dental LabChinaMakerRubber Dam Clamp——
SurgikarePakistanMakerCLAMP, RUBBER DAM——
T.A. Walthem & CompanyPakistanMakerCLAMP, RUBBER DAM——
Infirmary Medical SuppliesPakistanMakerCLAMP, RUBBER DAM——
Hexamed Pvt LtdPakistanMakerRubber Dam Clamp——
Nawaz and SonsPakistanMakerEEF - CLAMP, RUBBER DAM——
Karl Hammacher GmbHGermanyMakerKarl Hammacher GmbH——
Sabri IndustriesPakistanMakerCLAMP, RUBBER DAM——
NR Surgical CompanyPakistanMakerCLAMP, RUBBER DAM——
ASA DentalItalyMakerRubber Dam Clamp——
Power Dental USAUnited StatesMaker———
Swengg CoPakistanMakerRubber Dam Clamp / punches——
Empire Surgical Instruments CompanyPakistanMakerEMPSURG——
J&J InstrumentsUnited StatesMaker———
Kohler Medizintechnik GmbHGermanyMaker———
Sanctuary Health Sdn BhdMalaysiaMaker———
Phoenix Instruments, Inc.United StatesMaker———
USTOMED INSTRUMENTE GmbH & Co. KGGermanyMaker———
Gulmag InternationalPakistanMaker———
Nextcon InternationalPakistanMaker———
Sinntech Medical (Private) LimitedPakistanMaker———
Aseptico, Inc.United StatesContract manufacturerK-0 - RUBBER DAM CLAMP BICUSPID #0 · K-00 - RUBBER DAM CLAMP BICUSPID #00 · K-1 - RUBBER DAM CLAMP BICUSPID #1 · K-12A - RUBBER DAM CLAMP MOLAR #12A · +48172015
Integra LifeSciences CorporationUnited StatesContract manufacturerMiltex · Padgett22014
Wuxi Lyusmile Imp and Exp Co.,ltdChinaPrivate-label distributordental rubber dam frame · PLASTIC RUBBER DAM FRAME · RUBBER DAM CLAMP · rubber dam kit · +1——
Dentimed Sao Joao LLCUnited StatesRepacker / relabelerANGELUS——
TitanLinks Logistics LLCUnited StatesRepacker / relabelerDental Instrument——
Jmu Dental, Inc.United StatesRepacker / relabelerDental Dam——
Soher Med LimitedHong Kong SAR ChinaForeign exporterClamp——
STERIS CorporationUnited StatesContract sterilizer———
Aspen Surgical ProductsUnited StatesContract manufacturerSymmetry Surgical——
Premium Plus DentalUnited StatesListerCLAMP. RUBBER DAM——
Nordent MFG., Inc.United StatesContract manufacturerBrewer Rubber Dam Clamp Forcep——
TBS DentalUnited StatesRepacker / relabelerTBS INOX——
Wise Linkers LLCUnited StatesRepacker / relabelerArtman Instruments——
Sklar CorporationUnited StatesRepacker / relabelerRubber Dam Clamp——
Novo Surgical Inc.United StatesRepacker / relabeler———
Kash Sales Inc.CanadaForeign exporter———
Amnotec International Medical GmbHGermanyRepacker / relabeler———
Mainline Medical Dental SupplyCanadaForeign exporter———
Oketz Logistics LLCUnited StatesRepacker / relabeler———
Wexler Surgical Inc.United StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
21 Sep 2007K071615FIXAFLOSSSybron Dental Specialties
14 Feb 1992K915207DISPOSABLE RADIOLUCENT RUBBER DAM CLAMPBay Technical Products, Inc.
12 May 1978K780744BRINKER TISSUE RETRACTORSHygienic Dental Mfg., Co., The

Official records: FDA product classification for EEF · 21 CFR 872.6300.

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