Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Sterngold Dental, LLC — Predicate Candidate Screening

12 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

124 daysmedian FDA review time
169 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K171728MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm andSterngold Dental, LLC2017-09-281080
K153173MOR Implant SystemSterngold Dental, LLC2016-02-05940
K151928PUR Dental Implant SystemSterngold Dental, LLC2015-11-061150
K150968TRU Dental Implant SystemSterngold Dental, LLC2015-07-241020
K150250SternSnap Angled AttachmentSterngold Dental, LLC2015-06-111280
K142667Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, SSterngold Dental, LLC2015-01-071100
K142407Straight Stud AttachmentSterngold Dental, LLC2014-12-241180
K133791ORA 0.4MM [S], ORA 1.0MM [S], ORA 2.0MM [S], ORA 3.0MM [S], Sterngold Dental, LLC2014-04-161240
K132814SFI-BAR IMPLANT ABUTMENTSSterngold Dental, LLC2014-02-251690
K130183SFI BAR ABUTMENTSSterngold Dental, LLC2013-07-071630
K130408ERA MICRO 23 FEMALE ABUTMENT, ERA MICRO 30 FEMALE ABUTMENTSterngold Dental, LLC2013-07-011320
K111798STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10Sterngold Dental, LLC2012-06-013400

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda