Cerec Opti Spray
FDA 510(k) K080882 · Sirona Dental Systems GmbH
510(k) numberK080882
Submission
- Device name
- Cerec Opti Spray
- Applicant
- Sirona Dental Systems GmbH
Bensheim, DE - Received
- March 31, 2008
- Decision date
- April 11, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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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 |
More from Hdi, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K160099 | CEREC SpeedGlazeEIH · Traditional | 06/02/2016SE |
| K151045 | TENEO Dental Treatment Unit and AccessoriesEIA · Traditional | 07/24/2015SE |
| K150909 | INTEGO Family and AccesoriesEIA · Traditional | 07/17/2015SE |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 SprayEGS · Traditional | 07/02/2015SE |
| K150217 | Orthophos SLOAS · Traditional | 05/08/2015SE |
| K131319 | T1/T2/T3 Turbine FamilyEFB · Traditional | 05/30/2014SE |
| K132773 | Sidexis 4LLZ · Traditional | 12/11/2013SE |
| K123664 | Incoris ZiEIH · Traditional | 04/08/2013SE |
| K123952 | Cerec Blocs C inEIH · Traditional | 03/20/2013SE |
| K123070 | Galileos FamilyOAS · Traditional | 03/15/2013SE |
Questions and answers
When was Cerec Opti Spray cleared by the FDA?
Cerec Opti Spray (K080882) received a 510(k) decision of Substantially Equivalent on April 11, 2008, 11 days after the submission was received.
What is the product code of K080882?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.