Miracle Mix Caps Glass Ionomer Cement Incapsules
FDA 510(k) K913175 · G-C Intl. Corp.
510(k) numberK913175
Submission
- Device name
- Miracle Mix Caps Glass Ionomer Cement Incapsules
- Applicant
- G-C Intl. Corp.
Scottsdale, AZ, US - Received
- July 17, 1991
- Decision date
- December 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code EJJ
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| K053114 | SilverfilEJJ · Traditional | Dunia Perwira Manufacturing Sdn. Bhd. | 11/15/2005SE |
| K051010 | Securalloy, Septalloy NG 50 and Septalloy NG 70EJJ · Special | Septodont | 05/02/2005SE |
| K033434 | BestaloyEJJ · Traditional | We Dong Myung Dental Industrial Co., Ltd. | 11/12/2003SE |
| K032152 | Benco AdmixEJJ · Traditional | Southern Dental Industries, Inc. | 08/06/2003SE |
| K031658 | Benco SphericalEJJ · Traditional | Southern Dental Industries, Inc. | 07/29/2003SE |
| K020452 | High Silver ConventionalEJJ · Traditional | Ab Ardent | 05/07/2002SE |
| K011801 | Futura Topcap Non GAMMA-2EJJ · Traditional | Ab Ardent | 08/16/2001SE |
| K002811 | Ana 70 Non Gamma 2 Dispersed Phase Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
| K002810 | Ana 3000 SM Non Gamma 2 Modified Spherical Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
| K002808 | Ana 2000 Non Gamma 2 Extra High Copper Dental AlloyEJJ · Traditional | Nordiska Dental AB | 10/31/2000SE |
More from Nordiska Dental AB
| 510(k) | Device | Decision |
|---|---|---|
| K913884 | Fuji II LCEMA · Traditional | 10/30/1991SE |
| K901999 | Fuji Lining Cement Light CureEJK · Traditional | 07/31/1990SE |
| K902531 | Exaphase, Single Phase Impression MaterialEGW · Traditional | 07/13/1990SE |
| K896883 | GC Cervical CementEMA · Traditional | 07/06/1990SE |
| K895976 | Tooth Shade ResinEBF · Traditional | 12/22/1989SE |
| K892806 | Tuf-CoatELL · Traditional | 07/14/1989SE |
| K890830 | Denture ResinEBI · Traditional | 05/01/1989SE |
| K890829 | Unifast LCEBG · Traditional | 04/17/1989SE |
| K883770 | Resubmitted Ema Dentin CementEMA · Traditional | 11/30/1988SE |
| K880848 | Fuji Cap II Capsule & ApplierEMA · Traditional | 05/16/1988SE |
Questions and answers
When was Miracle Mix Caps Glass Ionomer Cement Incapsules cleared by the FDA?
Miracle Mix Caps Glass Ionomer Cement Incapsules (K913175) received a 510(k) decision of Substantially Equivalent on December 27, 1991, 163 days after the submission was received.
What is the product code of K913175?
The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.