Data / Medical devices / United States / Ortho Pro Dent LLC
Ortho Pro Dent LLC: FDA-registered device maker in Sarasota, FL, United States, 6 510(k) clearances
Ortho Pro Dent LLC is registered with the FDA (registration 3013410675) in Sarasota, FL, United States. It lists 16 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 23, 2012. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013410675
- Address
- 1903 Northgate Blvd,Northogate Executive Center suite 114, Sarasota, FL, United States, 34234
- Owner or operator
- Ortho Pro Dent LLC (10053964)
- Roles
- Repackager or relabeler
- First device listed
- January 26, 2017
- Registered through
- 2026
- Brand names listed
- 1st Molar band , 2nd Molar band, Adhesive bonding system, Automix Dual Cure Luting Cement, Band Plain promax bands, Bracket accessories; Crimpabal hooks;Crimpabal stopers , lingual buttons; Metal bracket; Orthodontic brackets, Chemical Cure Composite Restorative Material, Chemical Cure Composite Restorative Material; Chemical Cure Dentin/Enamel Bonding Adhesive, Chemical Cure Dentin/Enamel Bonding Adhesive and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 23, 2012 | K112574 | PRIME-DENT DUAL CURE COMPOSITE LUTING CEMENT | EMA | Substantially Equivalent | Prime Dental Manufacturing, Inc. | accessdata.fda.gov |
| May 27, 2009 | K090567 | ORTHODONTIC CERAMIC BRACKET | NJM | Substantially Equivalent | Star Dentech Korea., Corp | accessdata.fda.gov |
| November 7, 2002 | K022675 | PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL | EBF | Substantially Equivalent | Prime Dental Manufacturing, Inc. | accessdata.fda.gov |
| November 1, 2001 | K012761 | PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT | EBC | Substantially Equivalent | Prime Dental Manufacturing, Inc. | accessdata.fda.gov |
| October 24, 2001 | K012673 | PRIME-DENT ONE-STEP ORTHODONTIC ADHESIVE BONDING SYSTEM | DYH | Substantially Equivalent | Prime Dental Manufacturing, Inc. | accessdata.fda.gov |
| May 30, 2000 | K001108 | PRIME-DENT VISIBLE LIGHT CURE COMPOSITE RESTORATIVE MATERIAL | EBF | Substantially Equivalent | Prime Dental Manufacturing, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cement, Dental
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- All makers of Bracket, Metal, Orthodontic
- All makers of Tube, Orthodontic
- All makers of Band, Elastic, Orthodontic
Updated January 23, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.