Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Pelton & Crane Co. — Predicate Candidate Screening
14 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
220 days90th percentile
14clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K972249 | ORTHOPHOS PLUS AND ORTHOPHOS PLUS/CD | Pelton & Crane Co. | 1997-09-12 | 88 | 0 |
| K972168 | SIDEXIS DIGITAL RADIOGRAPHY SYSTEM | Pelton & Crane Co. | 1997-09-05 | 88 | 0 |
| K945117 | DELTA | Pelton & Crane Co. | 1997-02-28 | 864 | 0 |
| K962071 | SPIRIT S1/S2 | Pelton & Crane Co. | 1996-08-06 | 70 | 0 |
| K960819 | HELIODENT DS | Pelton & Crane Co. | 1996-03-29 | 29 | 0 |
| K950299 | CEREC 2 | Pelton & Crane Co. | 1995-05-23 | 118 | 0 |
| K946187 | SPIRIT II AND SPIRIT TREATMENT CENTER | Pelton & Crane Co. | 1995-03-01 | 71 | 1 |
| K950030 | HELIODENT MD | Pelton & Crane Co. | 1995-02-03 | 30 | 0 |
| K936068 | ORTHOPHOS 3/ ORTHOPHOS 3C | Pelton & Crane Co. | 1994-07-29 | 220 | 0 |
| K935390 | SIROLUX FANTASTIC | Pelton & Crane Co. | 1993-12-10 | 32 | 0 |
| K901672 | RESUBMITTED WATER PURIFIER FOR USE W/DENTAL TREAT | Pelton & Crane Co. | 1990-07-06 | 87 | 0 |
| K863484 | SIEMENS SIRONA(R) DENTAL CHAIR | Pelton & Crane Co. | 1986-09-19 | 10 | 0 |
| K837382 | OPTISON ULTRASONIC SCALER | Pelton & Crane Co. | 1983-05-06 | 63 | 0 |
| K760404 | BI-CENTRIC SYSTEM | Pelton & Crane Co. | 1976-08-23 | 14 | 5 |
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