Product code KMY— Dental
AQUALIZER MOUTHPIECE
- Classification name
- Positioner, Tooth, Preformed
- Device class
- Class 1
- Regulation
- 21 CFR 872.5525
- Advisory panel
- Dental
- Total cleared
- 12
- First cleared
- Most recent
Market context for product code KMY
FDA has cleared devices under product code KMY between 1978 and 1995, filed by 10 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.
Clearances per year
- 1995
- 1994
- 1993
- 1990
- 1989
- 1984
- 1983
- 1982
- 1978
Top applicants under product code KMY
Adverse events under product code KMY
product code KMY- Injury
- 1,457
- Total
- 1,457
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code KMY
- K931615 — NITE-GUIDE
- K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC
- K924351 — GLENROE ELASTIBITE STIMULATOR
- K925064 — RELAX-O-GUARD
- K924975 — THE ORTHOTRAINER
- K924974 — THE TMJ APPLIANCE
- K904128 — PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
- K891328 — PREFORMED TEMPLATE FOR TOOTH POSITIONER
- K833455 — REMOLDABLE CRANIOMANDIBULAR APPLIANCE
- K831793 — AQUALIZER MOUTHPIECE
- K821458 — DYNAMIC FUNTIONAL POSITIONER
- K780619 — PREFORMED TOOTH POSITIONER
Data sourced from openFDA. This site is unofficial and independent of the FDA.