Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285
FDA 510(k) K994211 · Dentsply Intl.
510(k) numberK994211
Submission
- Device name
- Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285
- Applicant
- Dentsply Intl.
Des Plaines, IL, US - Received
- December 14, 1999
- Decision date
- February 4, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4370
- Specialty
- General, Plastic Surgery
Surgical drapes with an antimicrobial agent are subject to 510(k) review, under the procedures established by the 21st Century Cures Act. This product code is the class II non-exempt counterpart of PUI.
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Questions and answers
When was Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285 cleared by the FDA?
Acucam Intraoral Camera Sheaths, Models 023545, 601111, 300407, 601285 (K994211) received a 510(k) decision of Substantially Equivalent on February 4, 2000, 52 days after the submission was received.
What is the product code of K994211?
The FDA product code is KKX – Drape, Surgical, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 878.4370.