Surgical devices · 21 CFR 872 Subpart E
Dental Prophylaxis Kit
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
- Companies listing it
- 97 makers
- Brands and models
- 5
- 510(k) clearances
- 00 in five years
- FDA name
- Dental Prophylaxis Kit
Companies that list NYC
9 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | SureSmile | 148 | 2026 |
| Denjoy Dental Co., Ltd. | China | Maker | Root Canal Instruments Kit | 1 | 2025 |
| Medline Industries, LP | United States | Maker | Dental Prophylaxis Kit | — | — |
| Robinson Healthcare Limited | United Kingdom | Maker | Instrapac | — | — |
| Peter Brasseler Holdings, LLC | United States | Maker | — | — | — |
| Sanctuary Health Sdn Bhd | Malaysia | Maker | Dental Dam Premium Kit | — | — |
| Cardinal Health 200, LLC | United States | Maker | — | — | — |
| Sotera Health LLC | United States | Contract manufacturer | — | — | — |
| STERIS Corporation | United States | Contract sterilizer | — | — | — |
Official records: FDA product classification for NYC · 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