PDT, Inc.
Kit Includes: T015E-U FlipTop™ Cassette 'E' – Utility T018FM Silicone Finger Mat 10.75”x 8” R245 Mirror Handle (Cone-Socket) R437 Lucas 86 T040 Tweezers COLLEGE T050 #5 Front Surface…
Kit Includes: T015E-U FlipTop™ Cassette ‘E’ → Utility T018FM Silicone Finger Mat 10.75”x 8” R245 Mirror Handle (Cone-Socket) R437 Lucas 86 T040 Tweezers COLLEGE T050 #5 Front Surface Mirror, Cone-Socket, (15/16′) T080 Tissue pliers ADSON T100 Retractor Caewood Minnesota 16 T102S Root elevator Seldin No. 301 straight Smooth Handle T104S Root elevator Seldin 34S Smooth Handle T118 Periosteal Elevator Molt 9 Hollow handle T235 Aspirating Anesthetic Syringe Medium T320 Elevator Fragment Ejector/Root Tip Pick, HEIDBRINK T704 Scalpel handle T714 TC Needle Holder CRILE WOOD T813 Scissors Goldman-Fox curved 12.5 T850 Miller-Colburn Bone File #1, Serrated
Who Else Makes It
Concentrated in Zhejiang (3), Shanghai (1), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Zhejiang Risheng Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 8 |
| Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 7 |
| ISA Mould Engineering Limted | Dongguan | Guangdong | Contract manufacturer | 4 |
Record
| Listed by | PDT, Inc., United States |
|---|---|
| FDA product code | EJY |
| Device type | Pliers, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-06-27 |
| Record revised | 2025-07-30 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R983 Basic Extraction Kit | In distribution | |
| T040 College Tweezers | In distribution | |
| T084 Corn Suture Pliers | In distribution | |
| R983 Rev C Basic Extraction Kit | In distribution | |
| T080 Tissue pliers ADSON | In distribution | |
| T042 Meriam Tweezers | In distribution | |
| T043 Cotton Pliers | In distribution | |
| T083 Semken-Taylor Tissue Pliers with Tooth (15cm) | In distribution | |
| T082 Semken-Taylor Tissue Pliers (15cm) | In distribution | |
| T085 Diamond Coated Corn Suture Pliers | In distribution | |
| T087 Diamond Coated Micro Straight Pliers (17.5cm) | In distribution | |
| T045 Locking Cotton Pliers | In distribution | |
| T081 Adson Tissue Pliers with Tooth | In distribution | |
| T086 Micro Straight Pliers (17.5cm) | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 49 |
| Henry Schein | Henry Schein, Inc. | 22 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 13 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 12 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 10 |
| J&J Instruments | J & J Instruments, LLC | 10 |
| Kohdent | Kohler Medizintechnik GmbH | 9 |
| Pomee | Pomee Corporation | 8 |
| Pliers | KLS-Martin L.P. | 8 |
| Leone SPA | Leone SPA | 7 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 7 |
| Aesthetic Aligner | Zatty Industria Comercio Importacao E Exportacao DE Instrumentacao Cirurgica E Odontologica Ltda | 7 |
Showing 12 of 102. All products under Pliers, 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.