Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Implantech Associates, Inc. · Predicate Candidate Screening
41 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
71 daysmedian FDA review time
117 days90th percentile
41clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K200610 | Customized Contour Implant | Implantech Associates, Inc. | 2020-12-23 | 289 | 0 |
| K191130 | Customized Contour Implant | Implantech Associates, Inc. | 2019-08-23 | 116 | 0 |
| K172389 | ePTFE-Coated Auricular Implant | Implantech Associates, Inc. | 2018-07-18 | 344 | 0 |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOM | Implantech Associates, Inc. | 2014-07-10 | 79 | 0 |
| K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX | Implantech Associates, Inc. | 2007-08-31 | 94 | 0 |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | Implantech Associates, Inc. | 2005-11-04 | 52 | 0 |
| K052505 | CALF IMPLANT, MODEL EC17-X | Implantech Associates, Inc. | 2005-11-04 | 52 | 0 |
| K013732 | GELZONE | Implantech Associates, Inc. | 2002-02-07 | 90 | 0 |
| K012419 | CONFORM SHEETING, MODEL IGEL | Implantech Associates, Inc. | 2001-10-24 | 86 | 0 |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL | Implantech Associates, Inc. | 2000-11-24 | 70 | 0 |
| K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | Implantech Associates, Inc. | 1997-11-07 | 52 | 0 |
| K964846 | IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING | Implantech Associates, Inc. | 1997-02-12 | 71 | 0 |
| K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | Implantech Associates, Inc. | 1996-10-03 | 76 | 0 |
| K962261 | IMPLANTECH WM NASAL-LABIAL IMPLANT | Implantech Associates, Inc. | 1996-08-19 | 68 | 0 |
| K943988 | IMPLANTECH NASAL LABIAL IMPLANT | Implantech Associates, Inc. | 1995-01-27 | 164 | 0 |
| K943644 | IMPLANTECH TEMPORAL IMPLANT | Implantech Associates, Inc. | 1994-10-18 | 83 | 0 |
| K941960 | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II | Implantech Associates, Inc. | 1994-08-17 | 117 | 0 |
| K942876 | IMPLANTECH DORSAL NASAL IMPLANT | Implantech Associates, Inc. | 1994-07-18 | 31 | 0 |
| K925426 | RIZZO NASAL IMPLANT | Implantech Associates, Inc. | 1993-05-12 | 197 | 0 |
| K921580 | BRINK PRE-MAXILLARY IMPLANT | Implantech Associates, Inc. | 1992-05-06 | 34 | 0 |
| K921581 | CHIN WAFER | Implantech Associates, Inc. | 1992-05-06 | 34 | 0 |
| K921582 | FLOWERS MEDIAL MALAR IMPLANT | Implantech Associates, Inc. | 1992-05-06 | 34 | 0 |
| K914297 | K.D. CHIN IMPLANT | Implantech Associates, Inc. | 1991-12-19 | 85 | 0 |
| K913761 | 3-D ACCUSCAN FACIAL IMPLANTS | Implantech Associates, Inc. | 1991-10-17 | 57 | 0 |
| K911513 | TRAPEZOIDAL MALAR IMPLANT | Implantech Associates, Inc. | 1991-07-01 | 88 | 0 |
| K911514 | ARTICULATED CHIN IMPLANT | Implantech Associates, Inc. | 1991-07-01 | 88 | 0 |
| K911515 | EXTENDED MALAR IMPLANT | Implantech Associates, Inc. | 1991-07-01 | 88 | 0 |
| K911516 | HIGH PROFILE CHIN IMPLANT | Implantech Associates, Inc. | 1991-07-01 | 88 | 0 |
| K910655 | COMBINED MALAR IMPLANT | Implantech Associates, Inc. | 1991-03-28 | 42 | 0 |
| K905267 | FLOWERS CHIN IMPLANT | Implantech Associates, Inc. | 1991-01-31 | 71 | 0 |
| K905268 | FLOWERS JOWL IMPLANT | Implantech Associates, Inc. | 1991-01-31 | 71 | 0 |
| K904656 | FLOWERS NASAL IMPLANT | Implantech Associates, Inc. | 1990-12-18 | 64 | 0 |
| K904657 | FLOWERS DORSAL COLUMELLA IMPLANT | Implantech Associates, Inc. | 1990-12-18 | 64 | 0 |
| K902941 | CURVILINEAR SILICONE CHIN IMPLANT | Implantech Associates, Inc. | 1990-08-02 | 30 | 0 |
| K902824 | EXTENDED CHIN IMPLANT STYLE I | Implantech Associates, Inc. | 1990-08-01 | 34 | 1 |
| K902825 | EXTENDED CHIN IMPLANT STYLE II | Implantech Associates, Inc. | 1990-08-01 | 34 | 0 |
| K902826 | ANATOMICAL MANDIBULAR IMPLANT STYLE I | Implantech Associates, Inc. | 1990-08-01 | 34 | 0 |
| K902827 | ANATOMICAL MANDIBULAR IMPLANT STYLE II | Implantech Associates, Inc. | 1990-08-01 | 34 | 0 |
| K901662 | ANATOMICAL MALAR IMPLANT | Implantech Associates, Inc. | 1990-05-01 | 21 | 0 |
| K894493 | BINDER SUBMALAR FACIAL IMPLANT | Implantech Associates, Inc. | 1989-10-27 | 100 | 0 |
| K895152 | BINDER SUBMALAR FACIAL IMPLANT II | Implantech Associates, Inc. | 1989-10-27 | 78 | 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