PARKELL, INC.
11 clearances · 6 inspections · 5 adverse events · aggregated across 3 source records
Scorecard
Events per device across the 913-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.
MAUDE reports per device
0.004 ▼
4 in the last 12 months
Higher volume than 86% of companies with 10+ devices
Recalls per device
0 →
0 in the last 12 months
Higher volume than 97% of companies with 10+ devices
These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.
Devices
913 device records · ordered by linked event volume.
| Brand | Model | Product codes | Primary DI | Linked events |
|---|---|---|---|---|
| DuraTip® | DURA30-US | ELC | 00810000522927 | 9 |
| DuraTip® | DURA30-PS | ELC | 00810000522903 | 3 |
| TurboSENSOR™ | D560110 | ELC | 00810000520527 | 1 |
| 20/20™ | S575 | EAX | 10810000526694 | 0 |
| 20/20™ | S475 | EAX | 10810000527585 | 0 |
| A&B ETCH FREE PORCELAIN PRIMER | 0 | |||
| ABSOLUTE DENTIN | 0 | |||
| ADD & BOND KIT | 0 | |||
| ADD&BOND™ | S260 | EBI | 00810000525072 | 0 |
| AMALGAMBOND PLUS - ADHESIVE AGENT | 0 | |||
| AMALGAMBOND PLUS - ADHESIVE KIT | 0 | |||
| AMALGAMBOND PLUS - BASE | 0 | |||
| AMALGAMBOND PLUS - HIGH PERFORMANCE ADDITIVE - POWDER | 0 | |||
| AMALGAMBOND® | S376 | KLE | M595S3760 | 0 |
| AMALGAMBOND® | S371 | KLE | 00810000529018 | 0 |
| AMALGAMBOND® | S374 | KLE | 00810000529032 | 0 |
| AMALGAMBOND® | S372 | KLE | M595S3720 | 0 |
| AMALGAMBOND® | S376 | KLE | 00810000529056 | 0 |
| AMALGAMBOND® | S372 | KLE | 00810000529025 | 0 |
| AMALGAMBOND® | S370 | KLE | 00810000529001 | 0 |
| AMALGAMBOND® | S370 | KLE | M595S3700 | 0 |
| Absolute Dentin™ | S307-K | EBF | 00810000525560 | 0 |
| Absolute Dentin™ | S301 | EBF | M595S3010 | 0 |
| Absolute Dentin™ | S300-K | EBF | 00810000525546 | 0 |
| Absolute Dentin™ | S300 | EBF | 00810000525027 | 0 |
| Absolute Dentin™ | S306 | EBF | M595S3060 | 0 |
| Absolute Dentin™ | S307 | EBF | 00810000525065 | 0 |
| Absolute Dentin™ | S304 | EBF | M595S3040 | 0 |
| Absolute Dentin™ | S301-K | EBF | 00810000525553 | 0 |
| Absolute Dentin™ | S301 | EBF | 00810000525034 | 0 |
Showing 1–30 of 913Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
| FEI | Name | Location | Last inspection | Watch |
|---|---|---|---|---|
| 2411797 | PARKELL, INC. | EDGEWOOD, NY, US | VAI |