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

Dentauraum, Inc. — Predicate Candidate Screening

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

95 daysmedian FDA review time
217 days90th percentile
24clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952870REMANIUM: CS & G-SOFTDentauraum, Inc.1995-07-27350
K952867REMANIUM:GM 700, GM 380, GM 800, GFHDentauraum, Inc.1995-07-27350
K952866REMATITAN TITANIUMDentauraum, Inc.1995-07-27350
K952865REMANIUM: 200,CS, 380, AND CDDentauraum, Inc.1995-07-26340
K952868DENTAURUM JACKET CROWN & ROOT POSTSDentauraum, Inc.1995-07-19270
K942667DENT-O-CRYL ORTHODONTIC ACRYLICDentauraum, Inc.1995-02-132520
K942666ORTHALGENAT IMPRESSION MATERIALDentauraum, Inc.1994-08-10650
K936151EXTRAORAL HEADGEARDentauraum, Inc.1994-08-012170
K942665ORTHOCENT: LIQUID AND POWDERDentauraum, Inc.1994-07-22460
K942668O-TRAY IMPRESSION TRAYSDentauraum, Inc.1994-07-22460
K935856DENTAURUM SPACE MAINTAINERDentauraum, Inc.1994-04-281410
K935139FASCINATION CERAMIC BRACKETDentauraum, Inc.1994-02-04990
K935140DENTAURUM STEEL LIGATURE WIRESDentauraum, Inc.1994-02-04990
K935144DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICDentauraum, Inc.1994-02-04990
K935155MERSHON BAND PUSHERDentauraum, Inc.1994-02-04990
K935156DENTAURUM BAND SEATER AND BAND SEATING INSTRUMENTSDentauraum, Inc.1994-02-03980
K935154DENTAURUM EXPANSION SCREWSDentauraum, Inc.1994-02-03980
K935153DENTAURUM BRACKET POSITIONING GAUGEDentauraum, Inc.1994-01-31950
K935122DENTAURUM METAL BRACKETSDentauraum, Inc.1994-01-31950
K935142DENTAURUM WIRESDentauraum, Inc.1994-01-31950
K935141DENTAURUM PLIERSDentauraum, Inc.1994-01-31950
K935152DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARDDentauraum, Inc.1994-01-31950
K935143DENTAURUM STAINLESS STEEL TUBINGDentauraum, Inc.1994-01-31950
K902018DENTAURUM CERAMIC DEBONDING UNITDentauraum, Inc.1991-04-033350

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