510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K864970Substantially Equivalent

Terumo Dental Needles

Terumo Medical Corp., Elkton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K864970 is the FDA 510(k) clearance record for TERUMO DENTAL NEEDLES, a class I device, cleared for Terumo Medical Corp. on under FDA product code DZM (Needle, Dental). FDA records list 157 510(k) clearances for Terumo Medical Corp., from to . As of , FDA records show no recalls naming K864970.

Clearance record

Decision date
Received
(78 days to decision)
Product code
DZM Needle, Dental
Regulation
21 CFR 872.4730
Device class
Class I
Review panel
Dental
Applicant
Terumo Medical Corp. 125 Blue Ball Rd., Elkton MD
Third party review
No

Clearances, product code DZM

Trailing 12 months

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

FDA records show no clearances under product code DZM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DZM, 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