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Tatum Surgical-Tapered Osteotome Kit

Suncoast Dental, Inc · Model Tatum Tapered Offset Osteotome Kit · UDI-DI 00083208044441

EMM Prescription

510(k) clearances

Adverse events

Recalls

132

Facilities

Description

Tatum Tapered Offset Osteotome Kit designed for use in bone expansion utilizing Tatum Tapered & Integrity Implants: Includes 24 instruments and 2 Autoclaveable cassettes: White - 3.0x15, 18, 21, 23, Blue - 3.5x12, 15, 18, & 21 Red - 4.0x12, 15, 18, & 21 Yellow - 4.5x12, 15, 18, & 21 Black - 5.0x12, 15, 18, & 21 Green - 6.0x12, 15, 18, & 21

Recalls

Date	Firm	Reason
2008-04-16	Biomet Microfixation, Inc.	The working tips of the Stella Osteotomes are thicker than specification.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.