510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981954Substantially Equivalent

Various Dental Implants with Various Abutments

Healthline Implants, Inc., Marion OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981954 is the FDA 510(k) clearance record for VARIOUS DENTAL IMPLANTS WITH VARIOUS ABUTMENTS, a class II device, cleared for Healthline Implants, Inc. on under FDA product code NRQ (Blade-Form Endosseous Dental Implant). FDA's definition for product code NRQ reads: "Device made of a material such as titanium or titanium alloy, that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a...". FDA records list one 510(k) clearance for Healthline Implants, Inc. As of , FDA records show no recalls naming K981954.

Clearance record

Decision date
Received
(235 days to decision)
Product code
NRQ Blade-Form Endosseous Dental Implant
Regulation
21 CFR 872.3640
Device class
Class II
Review panel
Dental
Applicant
Healthline Implants, Inc. 832 Marseilles-Galion Rd. W, Marion OH
510(k) summary
Statement
Third party review
No

Clearances, product code NRQ

Trailing 12 months

FDA records hold no clearances under product code NRQ in the trailing twelve months.

FDA records show no clearances under product code NRQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NRQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260