Mega Bite Registration - Dental Bite Registration Material
FDA 510(k) K030776 · Discus Dental, Inc.
510(k) numberK030776
Submission
- Device name
- Mega Bite Registration - Dental Bite Registration Material
- Applicant
- Discus Dental, Inc.
Culver City, CA, US - Received
- March 11, 2003
- Decision date
- May 9, 2003
- 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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| 510(k) | Device | Decision |
|---|---|---|
| K102639 | SL3GEX · Special | 12/01/2010SE |
| K101612 | Zen Cordless Prophy SystemEKX · Traditional | 06/30/2010SE |
| K101215 | NuanceEBF · Traditional | 05/12/2010SE |
| K093208 | SimplisealKIF · Traditional | 02/12/2010SE |
| K092417 | Insight Ultrasonic InsertsELC · Traditional | 12/11/2009SE |
| K073518 | Flashlite Rebel*EBZ · Traditional | 12/20/2007SE |
| K062176 | Relief Acp Oral Care GelLBH · Traditional | 01/10/2007SE |
| K052090 | Splash! Impression Material DeviceELW · Traditional | 08/05/2005SE |
| K051776 | Protege Ultrasonic InsertELC · Traditional | 07/13/2005SE |
| K033785 | Proactive Care Prophylaxis Paste with FluorideEJR · Traditional | 06/18/2004SE |
Questions and answers
When was Mega Bite Registration - Dental Bite Registration Material cleared by the FDA?
Mega Bite Registration - Dental Bite Registration Material (K030776) received a 510(k) decision of Substantially Equivalent on May 9, 2003, 59 days after the submission was received.
What is the product code of K030776?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.