Atlas FDA

REVOIS IMPLANT SYSTEM

FDA 510(k) clearance K063106 · decided 2007-06-11

Clearance details

K-number
K063106
Device name
REVOIS IMPLANT SYSTEM
Applicant
Curasan AG
Decision
Substantially Equivalent
Date received
2006-10-11
Decision date
2007-06-11
Days to decision
243 days
Clearance type
Abbreviated
Product code
NHA
Device class
2
Regulation number
872.3630
Medical specialty
Dental
Advisory committee
Dental
Location
Garner,, NC, US
Third-party review
No
Expedited review
No

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Neodent Scannable Healing Abutment (K253922)JJGC Indústria e Comércio de Materiais Dentários S.A.2026-06-15
Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™) (K254145)Smart Denture Conversions, LLC2026-06-11
DESS Dental Smart Solutions (K260564)Terrats Medical SL2026-06-09
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Elos Accurate® Denture Fixation System (K253774)Elos Medtech Pinol A/S2026-05-20
ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments (K253372)Hiossen, Inc.2026-05-14
Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue (K260460)Institut Straumann AG2026-05-07
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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
CERASORB DENTAL (P800035/S011)Curasan AG2003-12-08
PERI-OSS (P800035/S010)Curasan AG2001-10-04
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S007)Curasan AG1984-08-07
AUGMEN(TM) AKA SYNTHOGRAFT(TM) LG (P800035/S008)Curasan AG1983-11-10
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S004)Curasan AG1983-06-07
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S003)Curasan AG1982-11-08
SYNTHOGRAFT(TM) LARGE GRANULAR (LG) (P800035/S005)Curasan AG1982-08-09
SYNTHOGRAFT(TRICALCIUM PHOSPHATE-CERAMIC) (P800035/S002)Curasan AG1982-07-16