A-Dec 2182 Doctor's Unit
FDA 510(k) K925319 · A-Dec, Inc.
510(k) numberK925319
Submission
- Device name
- A-Dec 2182 Doctor's Unit
- Applicant
- A-Dec, Inc.
Newberg, OR, US - Received
- October 21, 1992
- Decision date
- December 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code KLC
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|---|---|---|---|
| K233921 | Luvis Chair (LC700C)KLC · Traditional | Dentis Co., Ltd. | 09/06/2024SE |
| K151987 | DCI Edge Dental Chair with Operative UnitKLC · Traditional | Dci | 06/01/2016SE |
| K071353 | Foshion Chair Mounted Dental, Model FJ48CKLC · Traditional | Shanghai Foshion Medical Instruments Co., Ltd. | 12/14/2007SE |
| K971063 | Optima Plus E Dental Chair; a Dental Chair; Excel ChairKLC · Traditional | King Dental Corp. | 06/03/1997SE |
| K963209 | Prostyle CompactKLC · Traditional | Planmeca Oy | 10/24/1996SE |
| K942870 | Ultima 2 Dental ChairKLC · Traditional | Dentech Corp. | 02/27/1995SE |
| K940950 | Kavo Systematica 1060KLC · Traditional | Kavo America | 12/29/1994SE |
| K925567 | E 4000 Dental Operating ChairKLC · Traditional | Dentalez Group | 03/10/1994SE |
| K925119 | A-Dec 1040 ChairKLC · Traditional | A-Dec, Inc. | 01/31/1994SE |
| K923534 | PM2002 ProlineKLC · Traditional | Planmeca USA, Inc. | 01/31/1994SE |
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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 |
Questions and answers
When was A-Dec 2182 Doctor's Unit cleared by the FDA?
A-Dec 2182 Doctor's Unit (K925319) received a 510(k) decision of Substantially Equivalent on December 9, 1993, 414 days after the submission was received.
What is the product code of K925319?
The FDA product code is KLC – Chair, Dental, With Operative Unit, a Class I (low risk) device regulated under 21 CFR 872.6250.