DeviceClearance

Product code NHA— Dental

DESS Dental Smart Solutions

Classification name
Abutment, Implant, Dental, Endosseous
Device class
Class 2
Regulation
21 CFR 872.3630
Advisory panel
Dental
Total cleared
713
First cleared
Most recent

FDA classification definition

“To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.”

— U.S. Food and Drug Administration, device classification record for product code NHA under 21 CFR 872.3630, via openFDA

Market context for product code NHA

FDA has cleared 713 devices under product code NHA between 1993 and 2026, filed by 169 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code NHA

Adverse events under product code NHA

product code NHA
Injury
1,270
Malfunction
2,860
Total
4,130

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 NHA

1–100 of 713

Data sourced from openFDA. This site is unofficial and independent of the FDA.