Rolence Ent., Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Rolence Ent., Inc.” (first 2002, latest 2009), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 86 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 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 |
|---|---|---|---|
| EBZ | Activator, Ultraviolet, For Polymerization | 4 | 4 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
Review panels
- Dental (5)
Most recent Rolence Ent., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K093084 | ROLENCE DENTAL HIGH SPEED HANDPIECE, RHP | EFB | 2009-12-16 | 76 |
| K023545 | ULTRA-LITE 200E LIGHT CURE UNIT | EBZ | 2002-12-30 | 69 |
| K020884 | EXCELLITE LIGHT CURE UNIT | EBZ | 2002-06-12 | 86 |
| K020877 | EXCELLITE TURBO LIGHT CURE UNIT | EBZ | 2002-06-12 | 86 |
| K020874 | ULTRA-LITE 5 TURBO LIGHT CURE UNIT | EBZ | 2002-06-12 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Rolence Ent., Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Rolence Enterprise Co. , Ltd. (12 510(k)s)
- Rolence Enteprise, Inc. (2 510(k)s)
- Rolence Enterprise, Inc. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Rolence Ent., Inc.?
FDA lists 5 510(k) clearances under the applicant name “Rolence Ent., Inc.” (first 2002, latest 2009), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Rolence Ent., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Rolence Ent., Inc. is 86 days.
Which FDA product codes appear under Rolence Ent., Inc.?
The most frequent FDA product codes under this applicant name are EBZ (Activator, Ultraviolet, For Polymerization, 4); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 5 Rolence Ent., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EBZ, Rolence Ent., Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.