510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802967Substantially Equivalent

Dispersalloy-Dispersed Phase Alloy Self-

Johnson & Johnson Professionals, Inc., Raynham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802967 is the FDA 510(k) clearance record for DISPERSALLOY-DISPERSED PHASE ALLOY SELF-, a class I device, cleared for Johnson & Johnson Professionals, Inc. on under FDA product code DZS (Capsule, Dental, Amalgam). FDA records list 206 510(k) clearances for Johnson & Johnson Professionals, Inc., from to . As of , FDA records show no recalls naming K802967.

Clearance record

Decision date
Received
(39 days to decision)
Product code
DZS Capsule, Dental, Amalgam
Regulation
21 CFR 872.3110
Device class
Class I
Review panel
Dental
Applicant
Johnson & Johnson Professionals, Inc. 325 Paramount Dr., Raynham MA
Third party review
No

Clearances, product code DZS

Trailing 12 months

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

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