Surgical devices · 21 CFR 872 Subpart E
Dental Instrument Depth Gauge
FDA device type “Gauge, Depth, Instrument, Dental”.
- Companies listing it
- 130103 makers
- Brands and models
- 269
- 510(k) clearances
- 80 in five years
- FDA name
- Gauge, Depth, Instrument, Dental
510(k) clearances per year, 1976–2026
Companies that list EIL
130 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | Bracket Height Gauge | 148 | 2026 |
| DiaDent Group International | South Korea | Maker | DIA-ENDORING · DIA-GP GAUGE · Endo Shaping Blocks · ENDO STOPS DIRECTIONAL ASST · +2 | 24 | 2026 |
| Ossvis Co., Ltd. | South Korea | Maker | Depth Gauge | 7 | 2024 |
| Sybron Dental Specialties | United States | Maker | EndoRing · SimpliCore Universal Verifier · SimpliCore Verifier for Zenflex One | 203 | 2026 |
| Paltop Advanced Dental Solutions Inc. | United States | Maker | Depth Gauge · Depth Probe for Prima Implant Systems · Drill Depth Probe · Profile Gauge · +1 | 7 | 2025 |
| Premier Dental Products Company | United States | Maker | PREMIER DEPTH GAUGE | 28 | 2026 |
| Keystone Dental Inc. | United States | Maker | Depth Probe for Prima Implant Systems · Radiographic Depth Gauge for Genesis Implant System · Surgical Depth Gauge for Renova Implant System · Surgical Depth Gauge for Stage-1 Single Stage Implant System · +1 | 7 | 2024 |
| Biotem Co., Ltd. | South Korea | Maker | AR_N Fixture Driver for Machine · AR_N Fixture Driver for Wrench · BR Fixture Driver for Machine · BR Fixture Driver for Wrench · +4 | 6 | 2023 |
| Pac-Dent Inc. | United States | Maker | Endo Aid Kit · Endo organizer | 5 | 2022 |
| HDI Inc. | South Korea | Maker | Denu Plastic Probe | 2 | 2022 |
| Dentium USA | United States | Maker | XDGL | 23 | 2022 |
| Essential Dental Systems, Inc. | United States | Maker | EDS Depth Gauge | 15 | 2023 |
| Ortho Organizers, Inc. | United States | Maker | Aluminum Height Gauge · Boone Gauge · Bracket Height Gauge Doubled Ended · High Heat Height Gauge | 8 | 2025 |
| Sewon Medix, Inc. | South Korea | Maker | Depth Gauge · DEPTH GAUGE(SDG) · DRILL STOPPER(DS507, DS508, DS510, DS511, DS513, DS515, DS607, DS608, DS610, DS611, DS613, DS615) · DRIVER CONNECTOR(DCS100, DCM120) · +18 | 2 | 2023 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Endo Block, Endo Ruler, Endo Gauge, Resin Block | 1 | 2025 |
| DentalMaster (Xiamen) Medical Technology Co., Ltd. | China | Maker | Depth Gauge | 1 | 2026 |
| Bicon, LLC | United States | Maker | Gauges | 18 | 2015 |
| Angelus Industria DE Produtos Odontologicos S/A | Brazil | Maker | ENDODONTIC RULER · ENDOMETRIC · INTERMEDIUM · SILICON STOP | 11 | 2021 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Basic Dental Implant Systems, Inc. | United States | Maker | Depth Gauge-Short&Long | 6 | 2008 |
| Airway Management, Inc. | United States | Maker | BITE REGISTRATION; TAP GAUGE | 5 | 2018 |
| Rhein'83 Srl | Italy | Maker | CUFF HEIGHT MEASURER | 4 | 2018 |
| Medimecca Co., Ltd. | South Korea | Maker | DG00 · DSR (Disk-up Sinus Reamer) | 4 | 2020 |
| Oco Biomedical | United States | Maker | DENTAL DEPTH GAUGE | 4 | 2013 |
| OT medical GmbH | Germany | Maker | Depth Gauge 2 | 3 | 2016 |
| Integra LifeSciences Corporation | United States | Maker | Integra · Miltex | 2 | 2014 |
| Storz AM Mark GmbH | Germany | Maker | Gauge | 2 | 2008 |
| GC Orthodontics | United States | Maker | GC Ortho | 2 | 2015 |
| SDS Swiss Dental Solutions AG | Switzerland | Maker | — | 2 | 2020 |
| Directa AB | Sweden | Maker | ContacEZ Incremental Thickness Gauge · IWANSSON MEASURING DEVICE | 1 | 2015 |
| Sawbros Industries Pvt., Ltd. | India | Maker | Boone guage marker | 1 | 2017 |
| Osung Mnd Co Ltd | South Korea | Maker | DG1 · LPC90 · LPC90S · OGBH018 · +5 | — | — |
| Zain's Medical Image | Pakistan | Maker | Backhaus Implant Caliper · BOLEY GAUGE · Boley Gauge, Ortho Style · BOON GAUGE · +15 | — | — |
| Schobell Industrial Ltda | Brazil | Maker | Boley gauge · Caliper, sharp tip · Castroviejo caliper · Iwanson gauge · +1 | — | — |
| Signor Seven International | Pakistan | Maker | Boley Gauge SKU-11-601 · Bracket Height Gauge 3.5mm-5mm (Adjustable 90° Head) SKU 19-122 · Duck Barren Double Head Ortho Gauge SKU 19-125 · Endo Finger Ruler, Ring Gauge SKU 19-128 · +13 | — | — |
| Dentaurum GmbH & Co. KG | Germany | Maker | Bracket positioning gauge · Depth | — | — |
| 株式会社ＹＤＭ | Japan | Maker | Boone Gauge YS-39 · Tension Gauge 5N YS-31 · Tension Gauge YS-31D Dial 5N | — | — |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dental measuring ruler | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · BOLEY · DOCTOR NICE | — | — |
| Dental Studio | South Korea | Maker | Castroviejo calliper · Crown gauge · Implant gauge | — | — |
| Shenzhen Denco Medical Co Ltd | China | Maker | Endo Block/Endo Ruler/Endo Gauge | — | — |
| HSG-S Corp | United States | Maker | EdgeEndo® · EdgeVerify · EndoRing® | — | — |
| Huanghua Promisee Dental Co., Ltd | China | Maker | Dental Ruler · Endo ruler · Measuring Guage · Microdont · +1 | — | — |
| Technimen Skillers | Pakistan | Maker | Boley Gauge · Bracket Gauge · Dental Gauge · Depth Gauge · +4 | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | Depth Gauge | — | — |
| Pomee Corporation | Pakistan | Maker | Lwansson Spring Caliper | — | — |
| US Endodontics, LLC | United States | Maker | Burkhart Verifier · Channels Verifier · EdgeVerify · OneFill Verifier · +1 | — | — |
| FKG Dentaire Sarl | Switzerland | Maker | Apical Verifier · FKG | — | — |
| Medcave Private Limited | Pakistan | Maker | Measuring Gauges | — | — |
| Panorama International | Pakistan | Maker | GAUGE, DEPTH, INSTRUMENT, DENTAL | — | — |
| Accompany Surgical | Pakistan | Maker | GAUGES | — | — |
| Shanghai Jolly Industrial Co., Ltd. | China | Maker | Endo measurement block | — | — |
| Lacigrus International | Pakistan | Maker | GAUGE, DEPTH, INSTRUMENT, DENTAL | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | GAUGE DEPTH INSTRUMENT DENTAL | — | — |
| Shanghai Lions Industrial Co., Ltd. | China | Maker | Endo measurement block | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | — | — | — |
| Confident Instruments | Pakistan | Maker | Artman Instruments | — | — |
| Denta Craft Instruments | Pakistan | Maker | GAUGES | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Otto Leibinger GmbH | Germany | Maker | Castroveijo Measuring Gauge · Measuring Gauge | — | — |
| Solventum US LLC | United States | Maker | Bracket Positioning Gauges | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| Acme Enterprises | Pakistan | Maker | TBS Dental | — | — |
| Surgicrafts | Pakistan | Maker | EIL / GAUGE, DEPTH, INSTRUMENT, DENTAL | — | — |
| Orthodontic Manufacturer SIA SRL | Italy | Maker | INTERPROXIMAL INCREMENTAL GAUGE · IPR · SIA ORTHODONTIC MANUFACTURER | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | DEPTH GAUGE | — | — |
| Cangzhou Lankang Medical Instruments Developing Co., Ltd. | China | Maker | Bite paper | — | — |
| Towne Brothers (Pvt) Ltd | Pakistan | Maker | EIL - GAUGE, DEPTH, INSTRUMENT, DENTAL | — | — |
| Intensiv SA | Switzerland | Maker | IPR-DC Set · IPR-DC010/3 · IPR-DC015/3 · IPR-DC020/3 · +5 | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Dental Depth Gauge | — | — |
| Daddy D Pro | Pakistan | Maker | Caliper Gauges | — | — |
| HuangHua DK Dental Co., LTD, | China | Maker | Endo Ruler; Microdont; ENDO MEASURE BLOCK; ENDO CLEAN BLOCK | — | — |
| Nopa Instruments Medizintechnik GmbH | Germany | Maker | BOLEY GAUGE | — | — |
| Everbrands, Inc. | United States | Maker | smartIPR Gauge | — | — |
| Tecomet | United States | Maker | PFR | — | — |
| Dentech Corp. | Japan | Maker | Dentech Corporation | — | — |
| Melpex Beauty Instruments | Pakistan | Maker | — | — | — |
| Jordco Inc | United States | Maker | ENDORING · Endoring e-Foam Inserts: Accessory · Endoring GelWell Cups: Accessory · Endoring High Density e-Foam Inserts: Accessory · +4 | — | — |
| Gesco Healthcare Private Limited | India | Maker | GESCO | — | — |
| Hebu Medical GmbH | Germany | Maker | Gauge, Depth, Instrument, Dental | — | — |
| Win Wings Corp. | Pakistan | Maker | GAUGE, DEPTH, INSTRUMENT, DENTAL | — | — |
| Ameda Instruments Company | Pakistan | Maker | Adam Pliers · Bracket Remover Pliers · Special Stop Pliers | — | — |
| Power Dental USA | United States | Maker | CALIPER | — | — |
| Ultra Surgical (Pvt.) Ltd. | Pakistan | Maker | GAUGE, DEPTH, INSTRUMENT, DENTAL | — | — |
| Alta Smiles, Inc | United States | Maker | — | — | — |
| Complexus Medical | United States | Maker | Depth Gage 1.5/2, 45mm, long · Depth Gage 2/2.4 45mm, long | — | — |
| J&J Instruments | United States | Maker | — | — | — |
| Precision Beauty & Dental Instruments LLC | United States | Maker | Precision Dental Instruments | — | — |
| Jining Orodeka Medical Equipment Co Ltd | China | Maker | Endodontic Measuring Probe | — | — |
| Julius Wirth | United States | Maker | Hu-Friedy | — | — |
| EOCA MD Pty Limited | Australia | Maker | SpaceCHQR | — | — |
| Calibaja Manufacturing, S.A. de C.V. | Mexico | Maker | — | — | — |
| Gunmed Technik AG | Switzerland | Maker | Model No. 801-0000 | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Taurus Engineering and Manufacturing, Inc. | United States | Maker | — | — | — |
| A. Handte Medizintechnik GmbH & Co. KG | Germany | Maker | — | — | — |
| Avalign Technologies | United States | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Gulmag International | Pakistan | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Rudolf Storz GmbH | Germany | Maker | — | — | — |
| Ivoclar Vivadent, AG | United States | Contract manufacturer | Bite Gauge · Bite Plane · Rim Former New | 94 | 2026 |
| B.t.i. Biotechnology | Spain | Foreign exporter | — | 14 | 2024 |
| American Orthodontics | United States | Contract manufacturer | Specialty Instruments (Boone Gauge) · Specialty Instruments (Force Gage) | 44 | 2026 |
| Young Innovations Inc | United States | Contract manufacturer | Cuff Height Measuring Tool · TITANIUM IMPLANT DEPTH GAUGE | 23 | 2025 |
| NuSmile, Ltd. | United States | Manufacturer | Endo-Block Ruler · File Organizer, Autoclavable Ruler · Z-Guage Ruler · Z-Ruler | 2 | 2026 |
| DSI Dental Solutions Ltd | Israel | Manufacturer | Plastic Probe | 2 | 2025 |
| Biomet Microfixation | United States | Manufacturer | Dental Gauge | 8 | 2021 |
| Suncoast Dental Corp. | United States | Repacker / relabeler | Depth Gauge | 2 | 1981 |
| Hager Worldwide, Inc. | United States | Manufacturer | — | 2 | 2005 |
| A. Titan Instruments, Inc. | United States | Contract manufacturer | Gauge | 1 | 2006 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL GAUGE · ENDO FILE RULER · ENDO GAUGE · ORTHODONTIC GAUGE | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| Ortho Arch Company Inc | United States | Repacker / relabeler | IPR | — | — |
| Diadent Group Intl., Inc. | Canada | Foreign exporter | DIA-ENDORING · DIA-GP GAUGE · Endo Shaping Blocks · ENDO STOPS DIRECTIONAL ASST · +2 | — | — |
| PDT Inc. | United States | Contract manufacturer | — | — | — |
| TBS Dental | United States | Repacker / relabeler | TBS INOX | — | — |
| Zarc4Endo S.A. | Spain | Private-label distributor | Endo-Block Ruler · Z-Gauge Ruler | — | — |
| Esthetic Orthodontic Company of America LLC | United States | Repacker / relabeler | SpaceCHQR | — | — |
| Peak Implements Inc | United States | Repacker / relabeler | GAUGE, DEPTH, INSTRUMENT, DENTAL | — | — |
| Sanicure BV | Netherlands | Foreign exporter | — | — | — |
| ambler surgical | United States | Repacker / relabeler | Ambler | — | — |
| Peter Brasseler Holdings, LLC | United States | Contract manufacturer | — | — | — |
| Med Saver, Inc. | United States | Repacker / relabeler | MSI Precision Specialty Instruments | — | — |
| Novo Surgical Inc. | United States | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 9 Jul 1991 | K911643 | ABIODENT PERIOTEMP(R) SYSTEM | Abiomed, Inc. |
| 13 Mar 1989 | K890493 | FLORIDA PROBE PERIODONTAL PROBE | Florida Probe Corp. |
| 13 Feb 1989 | K885075 | ABIOMED PERIOTEMP(TM) PROBE | Abiomed, Inc. |
| 5 Jan 1989 | K884813 | MODEL 200A ELECTRONIC FORCE-SENSING PROBE | Vine Valley Research |
| 27 Apr 1988 | K880209 | PERIODONTAL PROBE - AUTOPROBE | Dentsply Intl., Inc. |
| 31 Jul 1987 | K872098 | CREMEEN ALVEOLAR BONE CALIPER | Bowen & Company, Inc. |
| 10 Jul 1987 | K872215 | PERIO-TEST | Dr. Bernard Loewenthal |
| 22 Oct 1982 | K822793 | PIO ROOT CANAL INDICATOR | National Patent Development Corp. |
Official records: FDA product classification for EIL · 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