Pro-Lock
FDA 510(k) K952857 · Midwest Orthodontic Mfg.
510(k) numberK952857
Submission
- Device name
- Pro-Lock
- Applicant
- Midwest Orthodontic Mfg.
Columbus, IN, US - Received
- June 22, 1995
- Decision date
- September 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K261129 | OrthoFitDYH · Traditional | Spident Co., Ltd. | 07/02/2026SE |
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| K250015 | Ormco EtchFree Bonding System, Ormco EtchFree Bonding Primer, Ormco EtchFree AdhesiveDYH · Traditional | Ormco Corporation | 01/03/2025SE |
| K242537 | BracePaste Fluoride SealantDYH · Traditional | American Orthodontics Corp. | 08/27/2024SE |
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| K231817 | AlignerFlow LCDYH · Traditional | Voco GmbH | 12/01/2023SE |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP…DYH · Traditional | Tp Orthodontics, Inc. | 10/14/2022SE |
| K210115 | FiteBac CC OrthoSealDYH · Traditional | Largent Health, LLC | 07/29/2021SE |
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| K192682 | Orthocem, Ortho BiteDYH · Traditional | Dentscare Ltda | 08/14/2020SE |
More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K981433 | Orthodontic BracesDYW · Traditional | 06/25/1998SE |
| K955740 | GluflormaKLE · Traditional | 02/08/1996SE |
| K952856 | Light-Cure PCDYH · Traditional | 09/12/1995SE |
| K952855 | Pc-LockDYH · Traditional | 09/08/1995SE |
| K952858 | Light-CureDYH · Traditional | 09/05/1995SE |
| K900824 | Fluor-I-Chains(Tm) and Fluor-I-Ties(Tm)EJF · Traditional | 05/22/1990SE |
Questions and answers
When was Pro-Lock cleared by the FDA?
Pro-Lock (K952857) received a 510(k) decision of Substantially Equivalent on September 5, 1995, 75 days after the submission was received.
What is the product code of K952857?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.