Recall Z-2530-2016— Danville Materials, Inc.

Name: FDA recall Z-2530-2016
Creator: U.S. Food and Drug Administration
Published: 2016-06-24

Class II · Terminated

Class II FDA medical device recall by Danville Materials, Inc., initiated 2016-06-24, terminated 2016-12-09. It names one FDA 510(k) clearance: K982480. Product: Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).. Reason: The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim..

Recalling firm: Danville Materials, Inc.
Classification: Class II
Status: Terminated
Initiated: 2016-06-24
Terminated: 2016-12-09
Firm location: San Ramon, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K982480 — PERIOVIEW MODEL DV-1 FIBERSCOPE AND WINDOW SHEATH.Dentalview, Inc.·cleared 1998-09-15

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Perioscopy Sheath: Part number: 1008; The Perioscopy Sheath is a single-use sterile component used with the Perioscopy System, which is a medical device that features miniaturized digital video technology, and enables the healthcare professional to see magnified details of the tooth anatomy and deposits below the gum line (i.e. calculus root fractures, restoration margins, tooth decay).

Reason for recall

The Perioscopy Sheaths are currently provided with a label that indicates the Sheath has a 3 year shelf-life/expiry date. Danville Materials has become aware that validation data are not available to support the 3-year shelf-life/expiration dating claim.

Data sourced from openFDA. This site is unofficial and independent of the FDA.