PDT, Inc.
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette - Fixed Rack 15 with Standard Divider (R245) Cone Socket Mirror Handle (R311) DG 16 Explorer (R312) D11 Endo Spreader (R314) 1-3 Endo…
Kit Includes: (T015E-F) E-Series FlipTop™ Cassette – Fixed Rack 15 with Standard Divider (R245) Cone Socket Mirror Handle (R311) DG 16 Explorer (R312) D11 Endo Spreader (R314) 1-3 Endo Plugger (R315) 5-7 Endo Plugger (R316) 9-11 Endo Plugger (R317) Glick 1 (R318) 31L Endo Excavator (T046) Miller Articulating Paper Forceps (T047) Endo Locking Pliers (T050) #5 Mirror (15/16″) (T235) Aspirating Anesthetic Syringe Medium (T784) Ainsworth Rubber Dam Punch Forceps (T785) Ivory Rubber Dam Clamp Forceps (T786) Rubber Dam Frame (T863) Small Parts Basket
Who Else Makes It
Concentrated in Guangdong (4), Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
| Shumei Industrial (Hebei) Co., Ltd. | Cangzhou | Hebei | Contract manufacturer | 10 |
| Guang Zhou Medclear Medical Device Service Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | EKB |
| Device type | Explorer, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-04-30 |
| Record revised | 2025-07-25 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R170 Montana Explorer | In distribution | |
| R168 Explorer 2 | In distribution | |
| R183 Explorer 23 | In distribution | |
| R227 Explorer/Probe 23/UNC-12 | In distribution | |
| R169 Explorer ODU 11-12 ER | In distribution | |
| R226 Explorer/Probe 23/UNC-15 | In distribution | |
| R225 Explorer/Probe 23/WHO | In distribution | |
| R165 Explorer 6/23 | In distribution | |
| R171 Explorer TU17-23 | In distribution | |
| R166 Explorer 5 | In distribution | |
| R224 Explorer/Probe 23/OW | In distribution | |
| R943 PDT Endo Kit | In distribution | |
| R311 DG 16 Explorer | In distribution | |
| R167 Explorer ODU 11-12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 207 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 86 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 67 |
| Power Dental USA | Power Dental U.S.A. Inc. | 42 |
| Sklar® | Sklar Corporation | 39 |
| Premier Explorers | Premier Dental Products Co. | 35 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 32 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 28 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
Showing 12 of 77. All products under Explorer, Operative
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.