Prime Dental Manufacturing, Inc.: FDA clearances and approvals
Prime Dental Manufacturing, Inc. has 9 FDA 510(k) clearances (first 2000, latest 2012), across 5 product codes in 1 review panel. Median 510(k) review time: 76 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 139 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 5 | 5 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 1 | 1 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 1 | 1 |
| EIE | Dam, Rubber | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
Review panels
- Dental (9)
Most recent Prime Dental Manufacturing, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | EMA | 2012-01-23 | 139 |
| K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | EBF | 2002-11-07 | 87 |
| K021524 | LIGHT CURE DENTAL DAM | EIE | 2002-07-19 | 70 |
| K013970 | PRIME-DENT HEMA DESENSITIZER | EBF | 2002-02-19 | 78 |
| K012794 | PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT | EBF | 2001-11-05 | 76 |
| K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | EBC | 2001-11-01 | 76 |
| K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | DYH | 2001-10-24 | 71 |
| K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | EBF | 2000-05-30 | 55 |
| K994224 | PRIME-DENT CHEMICAL CURE COMPOSITE RESTORATIVE MATERIAL | EBF | 2000-01-31 | 47 |
Recalls
openFDA lists no recalls under a recalling firm named Prime Dental Manufacturing, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Prime Dental Manufacturing, Inc. have?
Prime Dental Manufacturing, Inc. has 9 FDA 510(k) clearances (first 2000, latest 2012), across 5 product codes in 1 review panel.
How long does FDA take to clear Prime Dental Manufacturing, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Prime Dental Manufacturing, Inc.'s cleared 510(k)s is 76 days.
What devices does Prime Dental Manufacturing, Inc. make?
Its most frequent FDA product codes are EBF (Material, Tooth Shade, Resin, 5); DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 1); EBC (Sealant, Pit And Fissure, And Conditioner, 1).
Has Prime Dental Manufacturing, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Prime Dental Manufacturing, Inc. Related entities may recall under other names.
Next steps
- See all 9 Prime Dental Manufacturing, Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBF, Prime Dental Manufacturing, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.