Jet Blue Bite
FDA 510(k) K051243 · Coltene/Whaledent AG
510(k) numberK051243
Submission
- Device name
- Jet Blue Bite
- Applicant
- Coltene/Whaledent AG
New York, NY, US - Received
- May 13, 2005
- Decision date
- June 23, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code ELW
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|---|---|---|---|
| K254112 | Dia-X Sil BiteELW · Traditional | DiaDent Group International | 03/19/2026SE |
| K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…ELW · Traditional | Vigodent Indústria E Comercio Ltda | 10/31/2025SE |
| K250969 | Jet Bite; Jet Blue Bite Fast; Jet Blue Bite SuperfastELW · Abbreviated | Dent4you AG | 06/27/2025SE |
| K241924 | Elastic Impression MaterialELW · Abbreviated | Beijing Okvd Biological Technology , Ltd. | 12/27/2024SE |
| 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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| K181500 | BRILLIANT CriosEBF · Traditional | 08/15/2018SE |
| K160800 | DuoCemEMA · Traditional | 11/16/2016SE |
| K152927 | Brilliant EverglowEBF · Traditional | 04/28/2016SE |
| K152243 | One Coat 7 UniversalKLE · Traditional | 12/09/2015SE |
| K150218 | Fill-Up!EBF · Traditional | 06/23/2015SE |
| K130137 | Biosonic Suvi Piezeoelectric Scaler and PolisherELC · Traditional | 08/23/2013SE |
| K121621 | SolocemEMA · Traditional | 01/08/2013SE |
| K112168 | ComponeerEBF · Traditional | 11/21/2011SE |
Questions and answers
When was Jet Blue Bite cleared by the FDA?
Jet Blue Bite (K051243) received a 510(k) decision of Substantially Equivalent on June 23, 2005, 41 days after the submission was received.
What is the product code of K051243?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.