Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

EAX — Predicate Candidate Screening

12 FDA 510(k) clearances under this product code; the 50 most recent screened below.

48 daysmedian FDA review time
224 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K946073ORALVUE DENTAL MIRRORHines Group , Ltd.1995-02-16710
K935906RANIR PLAX RXRanir/Dcp Corp.1994-09-022660
K941574RETRO MIRRORUnion Broach, Div. Moyco Industries, Inc.1994-05-18480
K935687NILDentalsafe Systems Pty., Ltd.1994-02-03660
K863767GLASS MOUTH MIRRORS, REUSABLEThe Medical Group, Inc.1986-10-30350
K863766DISPOSABLE MOUTH MIRRORS, SINGLE USE ONLYThe Medical Group, Inc.1986-10-30350
K833310FOGCUTTER DENTAL MOUTH MIRRORHti, Inc.1984-05-072240
K841199FIBERGLASS MOUTH MIRRORSHenry Schein, Inc.1984-04-25350
K833429PERI MIRROR/SALIVA EJECTORDentec, Inc.1983-12-22780
K830777ELECTRIC MOUTH MIRRORAlmore Intl., Inc.1983-04-06260
K821777BEACH MOUTH MIRRORPacific Dental Corp.1982-07-06190
K800919ORAVIEW BY WATER PIKTeledyne, Inc.1980-05-08170

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda