STERN ERA IMPLANT ABUTMENT

Implant, Endosseous, Root-form

STERNGOLD/IMPLAMED

The following data is part of a premarket notification filed by Sterngold/implamed with the FDA for Stern Era Implant Abutment.

Pre-market Notification Details

• Device ID: K914764
• 510k Number: K914764
• Device Name: STERN ERA IMPLANT ABUTMENT
• Classification: Implant, Endosseous, Root-form
• Applicant: STERNGOLD/IMPLAMED C/O MEDICAL DEVICE CONULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703
• Contact: Lynne Aronson
• Correspondent: Lynne Aronson; STERNGOLD/IMPLAMED C/O MEDICAL DEVICE CONULTANTS 45 WEST STREET, SUITE 2 Attleboro, MA 02703
• Product Code: DZE
• CFR Regulation Number: 872.3640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-10-22
• Decision Date: 1992-01-17

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841549113888	K914764	000
00841549101359	K914764	000
00841549101366	K914764	000
00841549101373	K914764	000
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00841549102370	K914764	000
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00841549102400	K914764	000
00841549102455	K914764	000
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00841549103155	K914764	000
00841549113895	K914764	000
00841549113901	K914764	000
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00841549102226	K914764	000
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08415491151766	K914764	000
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08415491151810	K914764	000