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

Sunrise Technologies, Inc. — Predicate Candidate Screening

18 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

91 daysmedian FDA review time
235 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K962192SUNRISE CURING LAMPSunrise Technologies, Inc.1996-09-03880
K942542SLASE 210 PLUS HOLMIUM LASER SYSTEMSunrise Technologies, Inc.1994-09-01970
K932997MICROPREP CAVITY PREPERATION SYSTEMSunrise Technologies, Inc.1994-04-253110
K933007SLASE 210 & SLASE 210 PLUS HOLMIUM LASER SYSTEMSSunrise Technologies, Inc.1994-01-102030
K933017MODEL 5030 SUCTION HANDPIECE SYSTEMSunrise Technologies, Inc.1993-07-26350
K931774UPGRADED PACKAGE FOR DLASE 300 PULSED DENTAL LASERSunrise Technologies, Inc.1993-07-221040
K9307898-WATT PULSED DENTAL LASER SYSTEMSunrise Technologies, Inc.1993-05-21940
K9308792.5 WATT PULSED DENTAL LASER SYSTEMSunrise Technologies, Inc.1993-05-21910
K925549SLASE 210 PLUS HOLMIUM LASER SYSTEMSunrise Technologies, Inc.1993-03-091260
K920248MODEL SLASE 210 HOLMIUM LASER SYSTEMSunrise Technologies, Inc.1992-07-211820
K920106ADL 400 ND;YAG LASER SYSTEM FOR INTRORAL SOFT TIS.Sunrise Technologies, Inc.1992-03-13640
K920107ADL 800 ND:YAG LASER SYSTEM FOR INTRAORAL TIS. SURSunrise Technologies, Inc.1992-03-13640
K912879MODEL SLASE 210 HOLMIUM (THC:YAG) LASER SYSTEMSunrise Technologies, Inc.1992-02-212350
K915352LASER FIBEROPTIC DELIVERY SYSTEMSunrise Technologies, Inc.1991-12-17210
K914677MODEL DLASE 500 ND:YAG LASE SYS:INTRA SFT TIS SURGSunrise Technologies, Inc.1991-11-08210
K914568MODEL DLASER 1000 ND;YAG LASER SYSTEMSunrise Technologies, Inc.1991-11-07230
K913488STI CONTACT 200 FIBEROPTIC DELIVERY SYSTEMSunrise Technologies, Inc.1991-09-10350
K900539MODEL DLASE 300 ND:YAG LASER SYSTEM: INTRAORALSunrise Technologies, Inc.1990-05-03870

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