Reliance Orthodontic Products, Inc.: FDA filings under this applicant name
FDA lists 32 510(k) clearances under the applicant name “Reliance Orthodontic Products, Inc.” (first 1988, latest 2021), across 9 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. Since 2017 the median was 143 days, against 120 days for all cleared 510(k)s in the same product codes. 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 | 2 | 92 |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 1 | 111 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 143 |
| 2021 | 2 | 131 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Reliance Orthodontic Products, Inc. took a median 143 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 23 | 23 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 2 |
| DYX | Lock, Wire, And Ligature, Intraoral | 1 | 1 |
| EBD | Coating, Filling Material, Resin | 1 | 1 |
| EBF | Material, Tooth Shade, Resin | 1 | 1 |
| EBG | Crown And Bridge, Temporary, Resin | 1 | 1 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 1 | 1 |
| EMA | Cement, Dental | 1 | 1 |
| NXC | Aligner, Sequential | 1 | 1 |
Review panels
- Dental (32)
Most recent Reliance Orthodontic Products, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K210349 | TKO Composite Bite Turbo Gel | EBF | 2021-07-20 | 162 |
| K210945 | Ultra SEP | KLE | 2021-07-08 | 100 |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | DYH | 2020-04-27 | 143 |
| K161684 | Quantum LB | DYH | 2016-10-06 | 111 |
| K130237 | PONTIC PAINT | NXC | 2013-04-05 | 64 |
| K123348 | CLEAR ALIGNER ADHESIVE | DYH | 2013-02-28 | 120 |
| K111814 | PADLOCK | DYH | 2011-09-14 | 79 |
| K101951 | LIGHT CURE RETAINER | DYH | 2010-10-26 | 106 |
| K083051 | FLOWTAIN & FLOWTAIN LV | DYH | 2009-02-20 | 129 |
| K073243 | LED PRO SEAL | EBD | 2008-02-08 | 81 |
22 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Reliance Orthodontic Products, 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.
- Reliance Medical Systems, LLC (27 510(k)s)
- Reliance Medical Corp. (3 510(k)s)
- Reliance Dental Mfg. Co. (2 510(k)s)
- Reliance Design & Manufacture Corp. (1 510(k)s)
- Reliance Design & Manufacturing Corp. (1 510(k)s)
- Reliance Industrial Co., Ltd. (1 510(k)s)
- Reliance Medical Products, Inc. (1 510(k)s)
- Reliance Products Corp. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Reliance Orthodontic Products, Inc.?
FDA lists 32 510(k) clearances under the applicant name “Reliance Orthodontic Products, Inc.” (first 1988, latest 2021), across 9 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 Reliance Orthodontic Products, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Reliance Orthodontic Products, Inc. is 80 days. Since 2017: 143 days, versus 120 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Reliance Orthodontic Products, Inc.?
The most frequent FDA product codes under this applicant name are DYH (Adhesive, Bracket And Tooth Conditioner, Resin, 23); KLE (Agent, Tooth Bonding, Resin, 2); DYX (Lock, Wire, And Ligature, Intraoral, 1).
Next steps
- See all 32 Reliance Orthodontic Products, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DYH, Reliance Orthodontic Products, 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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.