A-Dec 200 Dental System
FDA 510(k) K102234 · A-Dec, Inc.
510(k) numberK102234
Submission
- Device name
- A-Dec 200 Dental System
- Applicant
- A-Dec, Inc.
Newberg, OR, US - Received
- August 9, 2010
- Decision date
- November 24, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K240754 | N2EIA · Special | Megagen Implant Co., Ltd. | 03/21/2024SE |
More from Megagen Implant Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K213932 | A-dec 300, A-dec 500EIA · Traditional | 03/02/2022SE |
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| 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 |
| K082985 | A-Dec 334/335 Delivery SystemEIA · Traditional | 12/17/2008SE |
| 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 200 Dental System cleared by the FDA?
A-Dec 200 Dental System (K102234) received a 510(k) decision of Substantially Equivalent on November 24, 2010, 107 days after the submission was received.
What is the product code of K102234?
The FDA product code is EIA – Unit, Operative Dental, a Class I (low risk) device regulated under 21 CFR 872.6640.