A-Dec 334/335 Delivery System
FDA 510(k) K082985 · A-Dec, Inc.
510(k) numberK082985
Submission
- Device name
- A-Dec 334/335 Delivery System
- Applicant
- A-Dec, Inc.
Newberg, OR, US - Received
- October 7, 2008
- Decision date
- December 17, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
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| 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 |
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| K213932 | A-dec 300, A-dec 500EIA · Traditional | 03/02/2022SE |
| K133776 | A-Dec/W&H Electric Handpiece MotorEBW · Special | 05/28/2014SE |
| K102234 | A-Dec 200 Dental SystemEIA · Traditional | 11/24/2010SE |
| K100647 | A-Dec/W&H Synea Sonic Scaler Handpiece, Models ZA-55, ZA-55 L, ZA-55 LM, ZA-55M, SF1LMELC · Traditional | 07/09/2010SE |
| K082716 | A-Dec/W&H Alegra Air-Driven Highspeed Handpiece, Model TE-97, TE-98, A-Dec/W&H Alegra…EFB · Abbreviated | 01/15/2009SE |
| K082827 | A-Dec/W&H Profin Reciprocating Contra-Angle Handpiece AttachmentEFB · Abbreviated | 01/07/2009SE |
| K070663 | A-Dec/W&H Synea Air-Driven Highspeed Handpiece, Model TA-98, TA-97, A-Dec/W&H Synea…EFB · Abbreviated | 07/05/2007SE |
| K051657 | A-Dec Self-Contained Water SystemEIA · Traditional | 08/30/2005SE |
| K032757 | A-Dec Self-Contained Water System, Model 0.7 Liter Bottle & 2 Liter BottleEIA · Traditional | 12/10/2003SE |
| K032756 | A-Dec 532/533 Delivery System Model, 532/533EIA · Traditional | 12/04/2003SE |
Questions and answers
When was A-Dec 334/335 Delivery System cleared by the FDA?
A-Dec 334/335 Delivery System (K082985) received a 510(k) decision of Substantially Equivalent on December 17, 2008, 71 days after the submission was received.
What is the product code of K082985?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.