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510(k) K991436

STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION by Sterngold — Product Code DZE

K991436 is an FDA 510(k) premarket notification submitted by Sterngold for the device "STERNGOLD IMPLAMED NARROW PLATFORM DENTAL IMPLANTS AND RELATED PROSTHETICS AND INSTRUMENTATION". The FDA issued a decision of Substantially Equivalent on May 7, 1999. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Sterngold has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1999
Date Received
April 26, 1999
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implant, Endosseous, Root-Form
Device Class
Class II
Regulation Number
872.3640
Review Panel
DE
Submission Type

Other clearances by Sterngold

  • K092434 — STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM (November 10, 2009)
  • K041271 — STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM (October 28, 2004)
  • K023580 — STERNGOLD ACID ETCH DENTAL IMPLANT SYSTEM (January 17, 2003)
  • K022252 — STERNGOLD 1, MODEL 1127781 (September 19, 2002)
  • K021741 — CRITERTION, MODEL #1067511 (June 26, 2002)
  • K021045 — ERA IMPLANT (June 26, 2002)
  • K021367 — STERNGOLD 66, MODEL #1180230 (May 16, 2002)
  • K020949 — APOLLO, MODEL 1124525 (April 4, 2002)
  • K020391 — STERN MICRO ERA ATTACHMENT SYSTEM (March 8, 2002)
  • K003007 — GALAXY (November 17, 2000)

Other clearances for product code DZE

  • K261392 — TriActive Dental Implant System (September 17, 2026)
  • K260463 — ZEROS Dental Implant System (August 19, 2026)
  • K251188 — UNIQA® Dental Implants System (June 25, 2026)
  • K251232 — MegaGen Zygoma Dental Implant System (June 18, 2026)
  • K250806 — Dental Implant System (June 18, 2026)
  • K260006 — INOSS System (June 17, 2026)
  • K252731 — Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implan (May 12, 2026)
  • K252031 — Adin Long Dental Implant System (March 23, 2026)
  • K253334 — ZENEX Implant System_Short (R-System) (March 16, 2026)
  • K252168 — Straumann® BLC Implants - Indication Widening (March 10, 2026)

FDA data resources