Pre-Impression Conditioning Solution
FDA 510(k) K061427 · Dentsply Intl.
510(k) numberK061427
Submission
- Device name
- Pre-Impression Conditioning Solution
- Applicant
- Dentsply Intl.
York, PA, US - Received
- May 23, 2006
- Decision date
- June 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal…ELW · Traditional | Dent4you AG | 11/15/2024SE |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-BluELW · Traditional | B&E Korea Co., Ltd. | 02/13/2024SE |
| K223892 | DentMix VPS Impression MaterialELW · Traditional | Innovative Product Brands, Inc. | 04/27/2023SE |
| K213175 | No Stress ImpressELW · Traditional | No Stress Impress, LLC | 01/19/2023SE |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite…ELW · Traditional | Genoss Co., Ltd. | 12/15/2022SE |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular…ELW · Traditional | Hdi, Inc. | 11/07/2022SE |
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| 510(k) | Device | Decision |
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| K140347 | Ankylos C/X Implant SystemDZE · Traditional | 08/20/2014SE |
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| K123615 | Iris - High Strength Glass CeramicEIH · Traditional | 02/22/2013SE |
| K103244 | Qmix 2IN1 Endodontic Irrigating SolutionKJJ · Traditional | 02/14/2011SE |
| K093221 | Pre-Cemented Orthodontic Bracket System Extension IIDYH · Special | 10/30/2009SE |
| K083805 | Ankylos C/X Dental Implant SystemDZE · Traditional | 05/22/2009SE |
| K082198 | Durashield PlusLBH · Traditional | 10/29/2008SE |
| K072730 | Friadent Cercon and Ankylos Cercon Balance AbutmentsNHA · Traditional | 03/27/2008SE |
| K072989 | Axis SystemEFB · Traditional | 01/28/2008SE |
| K073117 | Dentin Desensitizer AgentLBH · Traditional | 12/19/2007SE |
Questions and answers
When was Pre-Impression Conditioning Solution cleared by the FDA?
Pre-Impression Conditioning Solution (K061427) received a 510(k) decision of Substantially Equivalent on June 26, 2006, 34 days after the submission was received.
What is the product code of K061427?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.