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Henry Schein
HENRY SCHEIN, INC. · Model 5701371 · UDI-DI 00304040107836
ELR
Prescription
10
510(k) clearances
131
Adverse events
2
Recalls
98
Facilities
Description
Stainless Steel Introductory Kit. 4 x yellow size 0 stainless steel posts, 4 x red size 1 stainless steel posts, 4 x blue size 2 stainless steel posts; 1 x yellow size 0 primary reamer, 1 x red size 1 primary reamer, 1 x blue size 2 primary reamer; 1 x yellow size 0 secondary drill, 1 x red size 1 secondary drill, 1 x blue size 2 secondary drill; 1 x extender; 1 x internal wrench, 1 x external wrench; 1 x gauge card.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-21 | Coltene Whaledent Inc | ParaPost Plus Titanium Posts contain stainless steel post that are a size 4 |
| 2009-03-20 | Dentsply Worldwide Headqrt | The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the thread |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.