Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sds Dental, Inc. · Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
73 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K990546 | DELSONIC 2000 | Sds Dental, Inc. | 1999-11-05 | 256 | 0 |
| K990545 | JETSONIC 2000 | Sds Dental, Inc. | 1999-08-11 | 170 | 0 |
| K964619 | DELIVERY SYSTEM(SDS 1400 XL)/DELIVERY SYSTEM CUSPIDOR(SDS145 | Sds Dental, Inc. | 1997-01-22 | 65 | 0 |
| K902864 | SURGICAL LIGHTING-CENTRA 450 | Sds Dental, Inc. | 1990-09-10 | 73 | 0 |
| K902865 | BAUMER SURGICAL TABLE | Sds Dental, Inc. | 1990-09-10 | 73 | 0 |
| K863011 | DENTATUS LS/EUROFLEX F-IV/ISOLIGHT REFLECT/CM-II | Sds Dental, Inc. | 1986-10-10 | 63 | 0 |
| K863007 | EUROFLEX F-IV, ISOFLEX III | Sds Dental, Inc. | 1986-10-01 | 54 | 0 |
| K863021 | CM-II, CM-I WATER UNIT | Sds Dental, Inc. | 1986-10-01 | 54 | 0 |
| K863013 | ISOLAX PEDAL SET | Sds Dental, Inc. | 1986-10-01 | 54 | 0 |
| K863014 | ISOPRAT F-III SET/ISOLAX CHAIR | Sds Dental, Inc. | 1986-10-01 | 54 | 0 |
| K863015 | ISOPRAT C-III SET/ISOCART III AUXILIARY UNIT | Sds Dental, Inc. | 1986-10-01 | 54 | 0 |
| K863012 | MINILAX SET | Sds Dental, Inc. | 1986-10-01 | 54 | 0 |
| K863016 | DENTATUS L SET | Sds Dental, Inc. | 1986-10-01 | 54 | 0 |
| K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | 1986-09-29 | 52 | 0 |
| K863010 | EUROCART SR-4, EUROCART M-IV, ISOCART III | Sds Dental, Inc. | 1986-09-26 | 49 | 0 |
| K863023 | CABINET II AUXILIARY UNIT | Sds Dental, Inc. | 1986-09-25 | 48 | 0 |
| K863017 | ISOLAX (GNATUS)/ISOLAX PEDAL/MINILAX | Sds Dental, Inc. | 1986-09-25 | 48 | 0 |
| K863009 | GNATUS ARTICULATOR 4.300/4.300GP 8.600 & ORTOFLEX | Sds Dental, Inc. | 1986-09-25 | 48 | 0 |
| K863018 | DENTATUS-S / L / LS / (GNATUS) | Sds Dental, Inc. | 1986-09-25 | 48 | 0 |
| K863024 | SERINGA TRIPLICE S.L. | Sds Dental, Inc. | 1986-09-25 | 48 | 0 |
| K863008 | -OM WEST 2000 GNATUS CHAIR | Sds Dental, Inc. | 1986-09-24 | 47 | 0 |
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