Last synced on 25 January 2026 at 3:41 am

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K952634
510(k) Type
Traditional
Applicant
OPTI-MAX
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/18/1995
Days to Decision
102 days
Submission Type
Statement

OPTI-MAX EXTERNALLY THREADED EXTERNAL-HEX DENTAL IMPLANT, TITANIUM PLASMA-SPRAY COATED, WITH HEALING SCREW

Page Type
Cleared 510(K)
PDF
PDF
* The FDA doesn't provide PDFs for all submissions.
510(k) Number
K952634
510(k) Type
Traditional
Applicant
OPTI-MAX
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
9/18/1995
Days to Decision
102 days
Submission Type
Statement