Dentist with Assistant Pack
FDA 510(k) K940864 · Sterile Concepts, Inc.
510(k) numberK940864
Submission
- Device name
- Dentist with Assistant Pack
- Applicant
- Sterile Concepts, Inc.
Richmond, VA, US - Received
- February 23, 1994
- Decision date
- August 2, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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|---|---|---|---|
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0)EIA · Traditional | Lakong Medical Devices Co., Ltd. | 08/07/2026SE |
| K251626 | Midmark Dental Delivery SystemEIA · Traditional | Midmark Corporation | 11/03/2025SE |
| K251491 | K5 Cart, K5 Mount, K5 SwingEIA · Special | Osstem Implant Company., Ltd. Chair Business | 07/17/2025SE |
| K243130 | Integral Dental UnitEIA · Traditional | Guangdong Yadeng Medical Apparatus Co., Ltd., | 06/27/2025SE |
| K242611 | Integral Dental UnitsEIA · Traditional | Mipont Medical Equipment Co., Ltd. | 05/27/2025SE |
| K250473 | Dental Delivery System Series 5 and Dental Delivery System Series 5 PlusEIA · Traditional | Dci International, LLC | 02/19/2025SE |
| K242404 | BDC Dental UnitEIA · Traditional | Bdc Dental Corporation , Ltd. | 02/07/2025SE |
| K231297 | Firstar Dental UnitEIA · Traditional | Firstar Dental Company | 01/27/2025SE |
| K233805 | K5EIA · Traditional | Osstem Implant Co., Ltd. Chair Business | 09/03/2024SE |
| K240754 | N2EIA · Special | Megagen Implant Co., Ltd. | 03/21/2024SE |
More from Megagen Implant Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K951231 | Orthopedic PacksGAN · Traditional | 12/01/1995SE |
| K951081 | OB/GYN PacksKNA · Traditional | 11/13/1995SE |
| K952539 | Radiology PacksLRO · Traditional | 07/14/1995SE |
| K951478 | General and Plastic Surgery PacksLRO · Traditional | 06/13/1995SE |
| K944139 | Dental Hygiene TrayLYY · Traditional | 12/15/1994SE |
| K943047 | IV Start KitsKMK · Traditional | 09/14/1994SE |
| K943090 | Suture Removal TraysFRG · Traditional | 08/22/1994SEKD |
| K943046 | Skin Staple Removal TraysMCZ · Traditional | 07/29/1994SESK |
| K920763 | Lacerattion TrayKDD · Traditional | 09/28/1992SESK |
Questions and answers
When was Dentist with Assistant Pack cleared by the FDA?
Dentist with Assistant Pack (K940864) received a 510(k) decision of Substantially Equivalent on August 2, 1994, 160 days after the submission was received.
What is the product code of K940864?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.