Atlas FDA

BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS

FDA 510(k) clearance K072642 · decided 2007-12-20

Clearance details

K-number
K072642
Device name
BIOMET 3I DENTAL ABUTMENTS AND RESTORATIVE COMPONENTS
Applicant
Biomet 3i, Inc.
Decision
Substantially Equivalent
Date received
2007-09-18
Decision date
2007-12-20
Days to decision
93 days
Clearance type
Traditional
Product code
NHA
Device class
2
Regulation number
872.3630
Medical specialty
Dental
Advisory committee
Dental
Location
Palm Beach Gardens, FL, US
Third-party review
No
Expedited review
No

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Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (K254145)Smart Denture Conversions, LLC2026-06-11
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Recalls involving this device

RecordFirmDate
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 2mm(H) Item: IWTH52 Dental implants recall (Z-2406-2016)Biomet 3i, LLC2016-08-12
Certain EP Healing Abutment 5mm(D) x 5.6mm(P) x 4mm(H) Item: IWTH54 Dental implants recall (Z-2407-2016)Biomet 3i, LLC2016-08-12
Certain Gingihue TM 15 degree Angled Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMPAP32G Dent recall (Z-2409-2016)Biomet 3i, LLC2016-08-12
Certain Gingihue 15 degree Angled Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IPAP454G. Dental i recall (Z-2410-2016)Biomet 3i, LLC2016-08-12
Certain Gingihue Post 5mm(D) x 5mm(P) x 2mm(H) Item: IWPP552G Dental implants recall (Z-2411-2016)Biomet 3i, LLC2016-08-12
Certain Gingihue Post 3.4mm(D) x 3.8mm(P) x 2mm(H) Item: IMAP32G Dental implants recall (Z-2412-2016)Biomet 3i, LLC2016-08-12
Certain Gingihue Post 4.1mm(D) x 5mm(P) x 4mm(H) Item: IAPP454G Dental implants recall (Z-2413-2016)Biomet 3i, LLC2016-08-12
Certain Pick-Up Coping 5mm(D) x 5mm(P) Item:IWIP55 Dental implants recall (Z-2416-2016)Biomet 3i, LLC2016-08-12
Certain Straight Healing Abutment 4.1mm(D) x 4.1mm(P) x 4mm(H) Item:ISHA44 Dental implants recall (Z-2417-2016)Biomet 3i, LLC2016-08-12
Certain Straight Pick-Up Coping 5.0mm(D) x 0mm(P) Item:IWIP50 Dental implants recall (Z-2418-2016)Biomet 3i, LLC2016-08-12
Gingihue 15 degrees Pre-Angled Post 4mm(D) x 5mm(P) x 2mm(H) Item: PAP452G Dental implants recall (Z-2419-2016)Biomet 3i, LLC2016-08-12
Gold-Tite Hexed Retaining Screw 3mm Item: GSH30 Dental implants recall (Z-2420-2016)Biomet 3i, LLC2016-08-12
Gold-Tite Square Uniscrew Item: UNISG Dental implants recall (Z-2421-2016)Biomet 3i, LLC2016-08-12
Preformance 15 degrees pre-angled post Dental implants recall (Z-2435-2016)Biomet 3i, LLC2016-08-12
Prep-Tite Post Dental implants recall (Z-2439-2016)Biomet 3i, LLC2016-08-12
Standard Abutment Dental implants recall (Z-2443-2016)Biomet 3i, LLC2016-08-12
Standard Abutment Temporary Screw Dental implants recall (Z-2445-2016)Biomet 3i, LLC2016-08-12
Temporary Healing Retention Cylinder Dental implants recall (Z-2447-2016)Biomet 3i, LLC2016-08-12
Temporary Hexed Cylinder Dental implants recall (Z-2448-2016)Biomet 3i, LLC2016-08-12
Temporary Non-Hexed Cylinder Dental implants recall (Z-2449-2016)Biomet 3i, LLC2016-08-12
Titanium Hexed Uniscrew Dental implants recall (Z-2450-2016)Biomet 3i, LLC2016-08-12
Titanium Square Uniscrew Dental implants recall (Z-2451-2016)Biomet 3i, LLC2016-08-12
Conical EP Healing Cap Dental implants recall (Z-2452-2016)Biomet 3i, LLC2016-08-12
Conical Healing Cap Dental implants recall (Z-2456-2016)Biomet 3i, LLC2016-08-12
Gingihue 15 Degree Pre-Angled Post Dental implants recall (Z-2464-2016)Biomet 3i, LLC2016-08-12
Gingihue Post Dental implants recall (Z-2465-2016)Biomet 3i, LLC2016-08-12
Gold Slotted Screw Dental implants recall (Z-2466-2016)Biomet 3i, LLC2016-08-12
Gold -Tite Hexed Retaining Screw Dental implants recall (Z-2467-2016)Biomet 3i, LLC2016-08-12
Healing Abutment Dental implants recall (Z-2468-2016)Biomet 3i, LLC2016-08-12
IOL Abutment and Screw Dental implants recall (Z-2474-2016)Biomet 3i, LLC2016-08-12
IOL Distal Extension Dental implants recall (Z-2475-2016)Biomet 3i, LLC2016-08-12
IOL Healing Cap Dental implants recall (Z-2476-2016)Biomet 3i, LLC2016-08-12
IOL Titanium Temporary Cylinder Dental implants recall (Z-2478-2016)Biomet 3i, LLC2016-08-12
Certain IOL Abutment Dental implants recall (Z-2486-2016)Biomet 3i, LLC2016-08-12
Certain Preformance 15 degrees Pre-Angled Post Dental implants recall (Z-2491-2016)Biomet 3i, LLC2016-08-12
Certain Preformance Post Dental implants recall (Z-2492-2016)Biomet 3i, LLC2016-08-12
Certain Provide Abutment Dental implants recall (Z-2494-2016)Biomet 3i, LLC2016-08-12
Certain Standard Abutment Dental implants recall (Z-2495-2016)Biomet 3i, LLC2016-08-12
Certain Straight Healing Abutment Dental implants recall (Z-2496-2016)Biomet 3i, LLC2016-08-12
Certain Temporary Hexed Cylinder Dental implants recall (Z-2498-2016)Biomet 3i, LLC2016-08-12
Certain Temporary Non-Hexed Cylinder Dental implants recall (Z-2499-2016)Biomet 3i, LLC2016-08-12
Certain Twist Lock TM Coping Dental implants recall (Z-2503-2016)Biomet 3i, LLC2016-08-12
Conical Abutment Dental implants recall (Z-2506-2016)Biomet 3i, LLC2016-08-12
Conical Abutment Gold Standard ZR TM Dental implants recall (Z-2507-2016)Biomet 3i, LLC2016-08-12
Certain EP Healing Abutment 4.1mm(D) x 5mm(P) x 2mm(H) Item: ITHA52 Dental implants recall (Z-2509-2016)Biomet 3i, LLC2016-08-12
Bellatek Encode Healing Abutment Dental implants recall (Z-2510-2016)Biomet 3i, LLC2016-08-12
Certain Bellatek Encode Healing Abutment Dental implants recall (Z-2512-2016)Biomet 3i, LLC2016-08-12
Certain Conical Abutment Dental implants recall (Z-2515-2016)Biomet 3i, LLC2016-08-12
Certain EP Healing Abutment Dental implants recall (Z-2517-2016)Biomet 3i, LLC2016-08-12
Certain Gingihue 15 degree Pre- Angled Post Dental implants recall (Z-2522-2016)Biomet 3i, LLC2016-08-12