Prophylaxis Pack
FDA 510(k) K950773 · Transidyne General Corp.
510(k) numberK950773
Submission
- Device name
- Prophylaxis Pack
- Applicant
- Transidyne General Corp.
Spartanburg, SC, US - Received
- February 21, 1995
- Decision date
- March 31, 1995
- Decision
- Unknown (SESK)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EGS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105)EGS · Traditional | Premium Plus (Dongguan) Limited | 09/15/2025SE |
| K240950 | Disposable Prophy AngleEGS · Abbreviated | Pacific Care Limited | 05/28/2025SE |
| K240183 | Star E900 Handpiece SeriesEGS · Traditional | Dentalez, Inc., Stardental Division | 09/19/2024SE |
| K230106 | General Cutting StraightEGS · Traditional | Nakanishi, Inc. | 05/24/2023SE |
| K222518 | FX ContraEGS · Traditional | Nakanishi, Inc. | 11/17/2022SE |
| K220874 | Smooth Drive contra angle and straight handpiecesEGS · Traditional | Lares Research | 11/07/2022SE |
| K220346 | Lotus Prophy AngleEGS · Traditional | Ajk Engineering, Inc. | 11/07/2022SE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional | Micro-Nx Co., Ltd. | 07/29/2022SE |
| K213139 | SURGmatic S15 L ProEGS · Traditional | Kavo Dental GmbH | 12/21/2021SE |
| K202960 | General Cutting Contra HandpieceEGS · Special | Nakanishi, Inc. | 10/27/2020SE |
More from Nakanishi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961217 | Bodily Fluid Disposal KitFXX · Traditional | 07/25/1996SE |
| K955658 | Laceration TrayFRG · Traditional | 01/25/1996SE |
| K950743 | Oral Procedure PackEGS · Traditional | 03/31/1995SESK |
| K950449 | Surgical BurGFF · Traditional | 03/01/1995SE |
| K950403 | Surgical Saw BladesGFA · Traditional | 02/21/1995SE |
| K924811 | I.V. Start KitLRS · Traditional | 06/17/1993SEKD |
| K924243 | Tracheostomy Care KitJOH · Traditional | 06/16/1993SEKD |
| K922339 | Suture Removal KitMCZ · Traditional | 12/11/1992SESK |
| K922041 | Primary Surgical Dressing TrayFMF · Traditional | 11/06/1992SEKD |
| K897133 | Model 1050 - Umbilical Cord Blood Sampling KitCBT · Traditional | 03/30/1990SE |
Questions and answers
When was Prophylaxis Pack cleared by the FDA?
Prophylaxis Pack (K950773) received a 510(k) decision of Unknown on March 31, 1995, 38 days after the submission was received.
What is the product code of K950773?
The FDA product code is EGS – Handpiece, Contra- And Right-Angle Attachment, Dental, a Class I (low risk) device regulated under 21 CFR 872.4200.