Home › Cranio Mandibular Rehab, Inc. › OraStretch® Extended Clip-On Mouthpiece
OraStretch® Extended Clip-On Mouthpiece
Cranio Mandibular Rehab, Inc. · Model CR1007 · UDI-DI 00850056079044
10
510(k) clearances
117
Adverse events (2 deaths)
2
Recalls
255
Facilities
Description
The OraStretch Extended Clip-On Mouthpiece is used with a OraStretch press device to adjust the fit of the mouthpieces. The catalog number X indicates the size to fit a Standard, Pediatric or Anterior device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2015-03-27 | Amtryke LLC | Product is being recalled due to complaints of cracked frames. |
| 2011-07-11 | North Coast Medical Inc | Potential for plastic D-ring to break during use and cause injury. |
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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.