Pro-Lock
FDA 510(k) K951236 · Health-Dent Intl., Inc.
510(k) numberK951236
Submission
- Device name
- Pro-Lock
- Applicant
- Health-Dent Intl., Inc.
Northlake, IL, US - Received
- March 20, 1995
- Decision date
- April 18, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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More from Dentscare Ltda
| 510(k) | Device | Decision |
|---|---|---|
| K972198 | Dent-Temp AcrylicEBG · Traditional | 12/17/1997SE |
| K953405 | Hema-BenzKLE · Traditional | 09/27/1995SE |
| K951220 | Hema-GluKLE · Traditional | 05/12/1995SE |
| K951381 | VilaDYH · Traditional | 04/27/1995SE |
| K951380 | Vila PCDYH · Traditional | 04/27/1995SE |
| K951235 | GirocDYH · Traditional | 04/20/1995SE |
| K951237 | Algi-BandELW · Traditional | 04/10/1995SE |
Questions and answers
When was Pro-Lock cleared by the FDA?
Pro-Lock (K951236) received a 510(k) decision of Substantially Equivalent on April 18, 1995, 29 days after the submission was received.
What is the product code of K951236?
The FDA product code is DYH – Adhesive, Bracket And Tooth Conditioner, Resin, a Class II (moderate risk) device regulated under 21 CFR 872.3750.