510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K043428Substantially Equivalent

Reliadent Dental Implant System

Bioinfera, Inc., Beachwood OH / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043428 is the FDA 510(k) clearance record for RELIADENT DENTAL IMPLANT SYSTEM, a class II device, cleared for Bioinfera, Inc. on under FDA product code NHA (Abutment, Implant, Dental, Endosseous). FDA's definition for product code NHA reads: "To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation". FDA records list 2 510(k) clearances for Bioinfera, Inc., from to . As of , FDA records show no recalls naming K043428.

Clearance record

Decision date
Received
(211 days to decision)
Product code
NHA Abutment, Implant, Dental, Endosseous
Regulation
21 CFR 872.3630
Device class
Class II
Review panel
Dental
Applicant
Bioinfera, Inc. 21205 Halworth Rd., Beachwood OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHA

Trailing 12 months
30 clearances under product code NHA in the twelve months to October 2026, June 2026 the highest month at 6.
Show the numbers
Monthly 510(k) clearances under FDA product code NHA, trailing twelve months
MonthClearances
November 20253
December 20254
January 20265
February 20261
March 20261
April 20262
May 20263
June 20266
July 20261
August 20261
September 20263
October 20260