Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Wallace A. Erickson & Co. — Predicate Candidate Screening
32 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
75 daysmedian FDA review time
212 days90th percentile
32clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K984503 | ALPHA BOND DENTIN/ENAMEL BONDING AGENT, MODEL 213-000 | Wallace A. Erickson & Co. | 1999-02-26 | 70 | 0 |
| K963922 | ALPHA-DENT ROOT CANAL SEALER & FILLER | Wallace A. Erickson & Co. | 1996-12-06 | 67 | 0 |
| K960667 | CENTRIX FLOFIL/CENTRIX FLOFIL WITH FLUORIDE | Wallace A. Erickson & Co. | 1996-07-02 | 133 | 0 |
| K960365 | ALPHA-DENT HEMA DESENTIZER(748-000)/WITH FLUORIDE(747-000) | Wallace A. Erickson & Co. | 1996-03-28 | 63 | 0 |
| K960165 | ALPHA-DENT COMPOSITE SURFACE SEALANT | Wallace A. Erickson & Co. | 1996-03-15 | 59 | 0 |
| K960122 | ALPHA-DENT TEMPORARY CROWN AND BRIDGE MATERIAL | Wallace A. Erickson & Co. | 1996-02-21 | 36 | 0 |
| K955521 | ALPHA-DENT COPAL CAVITY VARNISH | Wallace A. Erickson & Co. | 1996-01-24 | 51 | 0 |
| K955089 | ALPHA-DENT ZINC OXIDE EUGENOL TEMPORARY CEMENT | Wallace A. Erickson & Co. | 1995-12-13 | 36 | 0 |
| K942742 | ALPHA BOND-RITE II(TM) OR BOND-RITE II(TM) 2-PASTE ADHEV | Wallace A. Erickson & Co. | 1994-08-29 | 80 | 0 |
| K942727 | ALPHA BOUND-RITE I NO-MIX ADHESIVE OR BOND-RITE I NO-MIX ADH | Wallace A. Erickson & Co. | 1994-08-23 | 75 | 0 |
| K935625 | ALPHADENT LIGHT ACTIVATED ORTHODONTIC ADHESIVE BONDING SYSTE | Wallace A. Erickson & Co. | 1994-08-10 | 261 | 0 |
| K942767 | ALPHA-DENT C-R(R) HYBRID TYPE II COMPOSITE RESIN | Wallace A. Erickson & Co. | 1994-07-08 | 25 | 0 |
| K942596 | ALPHA-LOCK OR PRO-LOCK FLUORIDE RELEASING GLASS IONOMER BAND | Wallace A. Erickson & Co. | 1994-06-16 | 15 | 0 |
| K935436 | ALPHA-DENT GLASS IONOMER CEMENT, SELF CURED | Wallace A. Erickson & Co. | 1994-06-10 | 212 | 0 |
| K940120 | ALPHA-DENT | Wallace A. Erickson & Co. | 1994-02-25 | 46 | 0 |
| K930872 | ALPHA-DENT ROOT CANAL SEALER; WACH'S FORMULA | Wallace A. Erickson & Co. | 1994-02-01 | 347 | 0 |
| K934248 | ALPHA-DENT TISSUE CONDITIONER AND TEMPORARY RELINER | Wallace A. Erickson & Co. | 1993-12-08 | 100 | 0 |
| K932886 | ALPHA-DENT LIGHT ACTIVATED CORE BUILDUP BLUE PASTE | Wallace A. Erickson & Co. | 1993-09-29 | 107 | 0 |
| K930614 | ALPHA-DENT ORTHODONTIC ADHES TWO-PASTE BOND SYST | Wallace A. Erickson & Co. | 1993-06-17 | 132 | 0 |
| K921044 | ALPHA-DENT ORTHODONTIC ADHESIVE WITH ONE STEP BOND | Wallace A. Erickson & Co. | 1992-11-09 | 250 | 0 |
| K924635 | ALPHA-DENT PIT AND FISSURE SEALANT | Wallace A. Erickson & Co. | 1992-10-16 | 53 | 0 |
| K870579 | ALPHA-DENT PIT AND FISSURE SEALANT | Wallace A. Erickson & Co. | 1987-03-02 | 20 | 0 |
| K830044 | ODONTIC CENTRIC(BITE) REGIST. PASTE | Wallace A. Erickson & Co. | 1983-04-06 | 89 | 0 |
| K810407 | HYDROXYLATE ENAMEL BOND SYSTEM | Wallace A. Erickson & Co. | 1981-03-17 | 27 | 0 |
| K810498 | CENTRIC (BITE) REGISTRATION PASTE | Wallace A. Erickson & Co. | 1981-03-17 | 21 | 0 |
| K802535 | HYDROXYLATE DENTAL COMPOSITE RESTROATIVE | Wallace A. Erickson & Co. | 1980-12-18 | 64 | 0 |
| K790594 | DENTAL COMPOSITE RESTORATIVE MATERIAL | Wallace A. Erickson & Co. | 1979-06-15 | 81 | 0 |
| K790592 | IMPRESSION MATERIAL, RUBBER | Wallace A. Erickson & Co. | 1979-06-15 | 81 | 0 |
| K790595 | DENTAL ALGINATE IMPRESSION MATERIAL | Wallace A. Erickson & Co. | 1979-06-15 | 81 | 0 |
| K790596 | ENAMEL BOND SYSTEM | Wallace A. Erickson & Co. | 1979-06-15 | 81 | 0 |
| K790593 | DENTAL CEMENT, ZINC PHOSPHATE | Wallace A. Erickson & Co. | 1979-06-15 | 81 | 0 |
| K781687 | AUROFIL | Wallace A. Erickson & Co. | 1978-12-04 | 62 | 0 |
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