SPECTRA-SYSTEM ABUTMENTS 2008

Abutment, Implant, Dental, Endosseous

IMPLANT DIRECT LLC

The following data is part of a premarket notification filed by Implant Direct Llc with the FDA for Spectra-system Abutments 2008.

Pre-market Notification Details

• Device ID: K081101
• 510k Number: K081101
• Device Name: SPECTRA-SYSTEM ABUTMENTS 2008
• Classification: Abutment, Implant, Dental, Endosseous
• Applicant: IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301
• Contact: Thomas Gottenbos
• Correspondent: Thomas Gottenbos; IMPLANT DIRECT LLC 27030 MALIBU HILLS RD. Calabasas Hills, CA 91301
• Product Code: NHA
• CFR Regulation Number: 872.3630 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-04-17
• Decision Date: 2009-01-14
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841307132281	K081101	000
10841307126966	K081101	000
10841307108849	K081101	000
10841307108856	K081101	000
10841307108863	K081101	000
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10841307109150	K081101	000
10841307110880	K081101	000
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10841307110903	K081101	000
10841307110910	K081101	000
10841307110927	K081101	000
10841307110934	K081101	000
10841307112679	K081101	000
10841307126850	K081101	000
10841307126843	K081101	000
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00841307132298	K081101	000
00841307132311	K081101	000
00841307132328	K081101	000
00841307129625	K081101	000
00841307129632	K081101	000
00841307129656	K081101	000
00841307129663	K081101	000
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10841307129981	K081101	000
00841307126075	K081101	000
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00841307126112	K081101	000
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10841307126805	K081101	000
10841307112686	K081101	000
10841307112778	K081101	000
10841307112877	K081101	000
10841307114833	K081101	000
10841307114840	K081101	000
10841307115137	K081101	000
10841307115144	K081101	000
10841307115151	K081101	000
10841307115168	K081101	000
10841307115250	K081101	000
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10841307114802	K081101	000
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10841307112884	K081101	000
10841307112891	K081101	000
10841307112907	K081101	000
10841307113058	K081101	000
10841307113096	K081101	000
10841307113102	K081101	000
10841307113126	K081101	000
10841307113478	K081101	000
10841307113485	K081101	000
10841307113621	K081101	000
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10841307113645	K081101	000
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10841307113980	K081101	000
10841307113997	K081101	000
10841307114017	K081101	000
10841307123613	K081101	000