Pac-Dent Inc. (manufacturer, Brea, CA): 2 new FDA device listings, incl. system, optical impression, computer assisted design and manufacturing
Pac-Dent Inc. (Brea, California): 2 new FDA device listings, incl. system, optical impression, computer assisted design and manufacturing. Its amount of 2 is above the median of 1 (69th percentile). Dated 78 days ago, it serves as a historical benchmark. Score 70/100. As of 2026-10-28, from openFDA device registration and listing endpoint (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
amount: 2 · 69th percentile of 2,570 DeviceEstablishmentPulse records · 2.0x the median
Free preview: all 14 published fields of this record are shown below. Locked: 283 related CA DeviceEstablishmentPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Establishment | Pac-Dent Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device |
| Location | Brea, CA, US |
| New listings | 2 |
| Devices | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations; Cement, Dental |
| Product codes | NOF, EMA |
| Device classes | Class II |
| Medical specialties | Dental |
| Brand names | Rodin IO; PacTemp Automix NE |
| First new listing | 2026-08-19 |
| Latest new listing | 2026-08-19 |
| FDA registration number | 2086043 |
| Registration expires | 2027-12-31 |
| amount percentile | 69th of 2,570 (median 1, 2.0x median) |
| Peer records CSV (284 CA records) | 🔒 Click to unlock → |
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CSV columns: Establishment · Role · New listings · Devices · Latest listing · official source URL
- Source agency: openFDA device registration and listing endpoint (U.S. Food and Drug Administration)
- Record date: 2026-08-19
- Data refreshed: 2026-10-28
- Refunds on request within 14 days
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LIVE PUBLIC DATA Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) · Last refreshed: Wed, 28 Oct 2026 20:51:27 GMT
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Peer benchmark and outreach value: Pac-Dent Inc. and 284 California peers
- California DeviceEstablishmentPulse records like this one: 284
- Pac-Dent Inc.'s amount: 69th percentile of 2,570 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every California peer: $56,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
70 / 100 Score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- U.S. establishment.
What is the DeviceEstablishmentPulse record for Pac-Dent Inc. in Brea, California?
Pac-Dent Inc. (Brea, CA), a manufacturer, added 2 FDA device listings on 2026-08-19.
How does Pac-Dent Inc. compare to other California DeviceEstablishmentPulse records?
Its amount of 2 sits in the upper half (69th percentile) of 2,570 records; the median is 1. It is 78 days old; check the official source for later updates before acting. Its Score of 70/100 puts it among the stronger signals in this feed.
Pac-Dent Inc. vs. top 2 peers
| Organization | Location | Amount | Percentile | Record date |
|---|---|---|---|---|
| Pac-Dent Inc. | Brea, CA | 2 | 69th | 2026-08-19 |
| Endovascular Engineering, Inc. | Menlo Park, CA | 3 | 77th | 2026-10-14 |
| Inquis Medical, Inc. | Menlo Park, CA | 5 | 87th | 2026-10-16 |
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From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.