Statusblue
FDA 510(k) K013237 · Dmg USA, Inc.
510(k) numberK013237
Submission
- Device name
- Statusblue
- Applicant
- Dmg USA, Inc.
Ayer, MA, US - Received
- September 28, 2001
- Decision date
- October 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code ELW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K171772 | Ecosite Bulk FillEBF · Traditional | 01/31/2018SE |
| K160443 | TempoCem ClearEMA · Traditional | 09/30/2016SE |
| K130580 | Retraction PasteMVL · Traditional | 02/25/2014SE |
| K110759 | TempocemEMB · Abbreviated | 06/10/2011SE |
| K102603 | SA Flowable AdhesiveEBF · Abbreviated | 11/17/2010SE |
| K101710 | Luxatemp Ultra /StarEBG · Abbreviated | 09/28/2010SE |
| K100062 | Infiltration KitEBC · Abbreviated | 03/26/2010SE |
| K093338 | Self Adhesive Composite Luting CementEMA · Abbreviated | 02/12/2010SE |
| K093587 | Dental MercuryELY · Traditional | 01/21/2010SE |
| K081493 | Infiltration KitEBC · Abbreviated | 09/18/2008SE |
Questions and answers
When was Statusblue cleared by the FDA?
Statusblue (K013237) received a 510(k) decision of Substantially Equivalent on October 22, 2001, 24 days after the submission was received.
What is the product code of K013237?
The FDA product code is ELW – Material, Impression, a Class II (moderate risk) device regulated under 21 CFR 872.3660.