Paragon
FDA 510(k) K991481 · Lancer Orthodontics, Inc.
510(k) numberK991481
Submission
- Device name
- Paragon
- Applicant
- Lancer Orthodontics, Inc.
San Marcos, CA, US - Received
- April 28, 1999
- Decision date
- August 11, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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 |
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| K122069 | Storm Mini ScrewOAT · Traditional | 04/11/2013SE |
| K071192 | Blugoo HDELW · Traditional | 06/22/2007SE |
| K051552 | O.A.S.I. SystemDZE · Traditional | 09/19/2005SE |
| K904090 | Orthodontic Bonding Adhesive ControlDYH · Traditional | 04/29/1991SE |
| K904092 | Lancer Original, Sierra, General PurposeEJF · Traditional | 11/09/1990SE |
| K904093 | Buccal Tube, Buccal AttachmentEJF · Traditional | 11/07/1990SE |
| K904091 | Titanal,Sterling Spring,Dual Flex,Memorex,BendalloEJF · Traditional | 11/05/1990SE |
| K904094 | C.A.T.,Sinterline,Natural Arch,Microtwin,BiotorqueEJF · Traditional | 11/02/1990SE |
| K904089 | Perma MeshEJF · Traditional | 11/02/1990SE |
| K902075 | Intrigue Ceramic BracketNJM · Traditional | 08/06/1990SE |
Questions and answers
When was Paragon cleared by the FDA?
Paragon (K991481) received a 510(k) decision of Substantially Equivalent on August 11, 1999, 105 days after the submission was received.
What is the product code of K991481?
The FDA product code is EJJ – Alloy, Amalgam, a Class II (moderate risk) device regulated under 21 CFR 872.3070.