Surgical devices · 21 CFR 872 Subpart E
Periodontic File
FDA device type “File, Periodontic”.
- Companies listing it
- 5243 makers
- Brands and models
- 75
- 510(k) clearances
- 10 in five years
- FDA name
- File, Periodontic
510(k) clearances per year, 1976–2026
Companies that list EMR
52 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Premier Dental Products Company | United States | Maker | PREMIER PERIODONTIC FILE | 28 | 2026 |
| Hu-Friedy Mfg Co., LLC | United States | Maker | Hu-Friedy Mfg Co.,LLC | 8 | 2012 |
| Storz AM Mark GmbH | Germany | Maker | File | 2 | 2008 |
| Arnold Tuber Industries | United States | Maker | Periodontic File | 1 | 2009 |
| Schobell Industrial Ltda | Brazil | Maker | Buck file no. 11-12 · Dunlop file 1-2 · Dunlop File 2-2A · Dunlop File 2F-5F · +13 | — | — |
| Shanghai Kangqiao Dental Instruments Factory | China | Maker | Glass Ionomer Filling instrument KPICH · Periodontal files E1/E2/E3/E4/E5/FS3/4S · Plastic filling instrument KPFI GM1/GM2/GM3 · Plastic filling instrument KPFI NTI · +14 | — | — |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| Aspen Surgical Products | United States | Maker | Symmetry Surgical | — | — |
| Cislak Manufacturing, Inc. | United States | Maker | Cislak · Zoll Dental | — | — |
| Falcon Surgical Co. (Pvt.) Ltd. | Pakistan | Maker | File, Periodontic | — | — |
| Medcave Private Limited | Pakistan | Maker | Periodontic File | — | — |
| Nordent MFG., Inc. | United States | Maker | NORDENT PERIODONTAL FILES | — | — |
| Panorama International | Pakistan | Maker | FILE, PERIODONTIC | — | — |
| Lacigrus International | Pakistan | Maker | FILE, PERIODONTIC | — | — |
| Comfort Surgical Instruments | Pakistan | Maker | periodontic file | — | — |
| Aesculap AG | Germany | Maker | FILE | — | — |
| PDT Inc. | United States | Maker | PDT, Inc. | — | — |
| Adolf Schweick Hardt GmbH & Co | Germany | Maker | PERIODONTAL FILE | — | — |
| Medisporex Private Limited | Pakistan | Maker | MEDIS | — | — |
| Dentag SRL | Italy | Maker | DENTAG | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Maker | FILE | — | — |
| Shanghai Medical Instruments (Group) Ltd. Corp. | China | Maker | PERIODONTIC FILE | — | — |
| Surgiscape | Pakistan | Maker | FILE, PERIODONTIC | — | — |
| Choose Surgical Instruments | Pakistan | Maker | FILE, PERIODONTIC | — | — |
| Y. Z. Corporation | Pakistan | Maker | YZ Periodontic Files | — | — |
| Dimeda Instrumente GmbH | Germany | Maker | DIMEDA | — | — |
| Med2B Ltd. | Germany | Maker | FILE, PERIODONTIC | — | — |
| Hospimed Mfg | Pakistan | Maker | File, Periodontic | — | — |
| Guangzhou OO Medical Scientific Limited | China | Maker | OO Dental | — | — |
| Zepf Medical Instrum | Germany | Maker | FILE | — | — |
| Sino Ortho Limited | China | Maker | protaper file | — | — |
| Tontarra Medizintechnik GmbH | Germany | Maker | 20-0406 | — | — |
| Power Dental USA | United States | Maker | FILE, PERIODONTIC | — | — |
| Funing Meitedental Factory | China | Maker | Dental Files | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Kazan Medical Instruments Plant | Russia | Maker | — | — | — |
| Kohler Medizintechnik GmbH | Germany | Maker | — | — | — |
| Armm, Inc. | United States | Maker | Subantral Membrane Elevators | — | — |
| Phoenix Instruments, Inc. | United States | Maker | — | — | — |
| Devemed GmbH | Germany | Maker | — | — | — |
| Helmut Zepf Medizintechnik GmbH | Germany | Maker | — | — | — |
| Nextcon International | Pakistan | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | ANGELUS | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | File | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | File | — | — |
| Sklar Corporation | United States | Repacker / relabeler | File | — | — |
| Sontec Instruments Inc | United States | Repacker / relabeler | FILE, PERIODONTIC | — | — |
| 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 |
|---|---|---|---|
| 1 Mar 1983 | K830109 | CIMPAT | North Pacific Dental, Inc. |
Official records: FDA product classification for EMR · 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