Disposable Barrier Sleeves and Covers
FDA 510(k) K160232 · Dentsply International, Inc.
510(k) numberK160232
Submission
- Device name
- Disposable Barrier Sleeves and Covers
- Applicant
- Dentsply International, Inc.
York, PA, US - Received
- February 1, 2016
- Decision date
- June 7, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEM – Dental Barriers And Sleeves
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Intended to serve as a disposable barrier for dental instruments to reduce the risk of cross contamination between dental patients.
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Questions and answers
When was Disposable Barrier Sleeves and Covers cleared by the FDA?
Disposable Barrier Sleeves and Covers (K160232) received a 510(k) decision of Substantially Equivalent on June 7, 2016, 127 days after the submission was received.
What is the product code of K160232?
The FDA product code is PEM – Dental Barriers And Sleeves, a Class II (moderate risk) device regulated under 21 CFR 878.4370.