Ormco System 1+ (TM)
FDA 510(k) K941015 · Ormco Corp.
510(k) numberK941015
Submission
- Device name
- Ormco System 1+ (TM)
- Applicant
- Ormco Corp.
Glendora, CA, US - Received
- March 3, 1994
- Decision date
- March 31, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K240501 | Spark Clear Aligner SystemNXC · Traditional | 10/11/2024SE |
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| K172845 | Symetri ClearNJM · Traditional | 01/31/2018SE |
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| K141611 | Lythos Digital Impression SystemNOF · Traditional | 12/05/2014SE |
| K123118 | Insignia DigicastDYW · Traditional | 03/26/2013SE |
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Questions and answers
When was Ormco System 1+ (TM) cleared by the FDA?
Ormco System 1+ (TM) (K941015) received a 510(k) decision of Substantially Equivalent on March 31, 1994, 28 days after the submission was received.
What is the product code of K941015?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.