IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR

Implant, Endosseous, Root-form

STERNGOLD

The following data is part of a premarket notification filed by Sterngold with the FDA for Impla-med Low Margin Abutments, Screwdriver, Polishing Protector.

Pre-market Notification Details

• Device ID: K946198
• 510k Number: K946198
• Device Name: IMPLA-MED LOW MARGIN ABUTMENTS, SCREWDRIVER, POLISHING PROTECTOR
• Classification: Implant, Endosseous, Root-form
• Applicant: STERNGOLD 13794 N.W. 4TH. STREET, SUITE 209 Sunrise, FL 33325
• Contact: Chad J Patterson
• Correspondent: Chad J Patterson; STERNGOLD 13794 N.W. 4TH. STREET, SUITE 209 Sunrise, FL 33325
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-12-20
• Decision Date: 1995-06-14

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08415491020390	K946198	000
00841549111198	K946198	000
00841549111204	K946198	000
00841549111211	K946198	000
00841549111143	K946198	000
00841549111150	K946198	000
00841549111167	K946198	000
00841549111174	K946198	000
00841549111181	K946198	000
08415491019950	K946198	000
08415491020246	K946198	000
08415491020376	K946198	000
08415491020383	K946198	000
00841549111136	K946198	000