Almore Intl., Inc.: FDA filings under this applicant name
FDA lists 21 510(k) clearances under the applicant name “Almore Intl., Inc.” (first 1980, latest 1986), across 17 product codes in 3 review panels. Median 510(k) review time under this name: 48 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 |
|---|---|---|---|
| EJL | Bur, Dental | 2 | 2 |
| EJP | Articulators | 2 | 2 |
| HTD | Forceps | 2 | 2 |
| EAX | Mirror, Mouth | 1 | 1 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | 1 | 1 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 | 1 |
| ECB | Unit, Syringe, Air And/Or Water | 1 | 1 |
| EEG | Heat Source For Bleaching Teeth | 1 | 1 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
| EIY | Instrument, Filling, Plastic, Dental | 1 | 1 |
Plus 7 more product codes.
Review panels
- Dental (15)
- Ophthalmic (2)
- General and Plastic Surgery (2)
Most recent Almore Intl., Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K862851 | ALMORE FACE MASK | — | 1986-08-12 | 14 |
| K854692 | MONARCH II BLEACHING INSTRUMENT | EEG | 1986-05-12 | 172 |
| K854696 | OP II VISIBLE LIGHT CURING SYSTEM | EBZ | 1986-03-26 | 125 |
| K854691 | DIAMOND BURS-HANDPIECE | EJL | 1986-03-25 | 124 |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | EJL | 1986-03-25 | 124 |
| K854700 | EZ-ON TUBING CONDITIONER (LUBRICANT) | — | 1986-03-12 | 111 |
| K854702 | PLASTIC MOUNTING RINGS | EJP | 1986-03-06 | 105 |
| K854701 | RETRACT-A-CORD | JES | 1986-03-06 | 105 |
| K854697 | TUBING HANDPIECE REPLACEMENT | EFB | 1986-03-06 | 105 |
| K854699 | TUBING SYRING | ECB | 1986-01-06 | 46 |
11 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Almore Intl., 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Almore Intl., Inc.?
FDA lists 21 510(k) clearances under the applicant name “Almore Intl., Inc.” (first 1980, latest 1986), across 17 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Almore Intl., Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Almore Intl., Inc. is 48 days.
Which FDA product codes appear under Almore Intl., Inc.?
The most frequent FDA product codes under this applicant name are EJL (Bur, Dental, 2); EJP (Articulators, 2); HTD (Forceps, 2).
Next steps
- See all 21 Almore Intl., Inc. clearances with predicates and recalls
- Run predicate analysis for product code EJL, Almore Intl., 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.