Sherlock

Abutment, Implant, Dental, Endosseous

Open Implants, LLC

The following data is part of a premarket notification filed by Open Implants, Llc with the FDA for Sherlock.

Pre-market Notification Details

• Device ID: K193335
• 510k Number: K193335
• Device Name: Sherlock
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: Open Implants, LLC 800 West Cummngs Ave, Suite 4900 Woburn, MA 01801
• Contact: Tamara Nazzal
• Correspondent: Chris Brown; Aclivi, LLC 6455 Farley Road Pinckney, MI 48169
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2019-12-02
• Decision Date: 2020-03-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
D86336740	K193335	000
D86349380	K193335	000
D86349350	K193335	000
D86349340	K193335	000
D86349330	K193335	000
D86349320	K193335	000
D86349310	K193335	000
D86349300	K193335	000
D86349290	K193335	000
D86349280	K193335	000
D86349270	K193335	000
D86349260	K193335	000
D8633899	K193335	000
D86349390	K193335	000
D86349400	K193335	000
D86336730	K193335	000
D86357510	K193335	000
D86357500	K193335	000
D86353280	K193335	000
D86353270	K193335	000
D86353260	K193335	000
D8635324	K193335	000
D86353240	K193335	000
D86349440	K193335	000
D86349430	K193335	000
D86349420	K193335	000
D86349410	K193335	000
D8633894	K193335	000