Dentsply International, Inc.: FDA filings under this applicant name

FDA lists 59 510(k) clearances under the applicant name “Dentsply International, Inc.” (first 2001, latest 2016), across 27 product codes in 1 review panel. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

Caduvo groups this applicant name under Dentsply Sirona, based on public ownership records.

510(k) clearances per year

Top product codes

Plus 17 more product codes.

Review panels

• Dental (59)

Most recent Dentsply International, Inc. 510(k) clearances

49 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Dentsply International, 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.

Device clinical trials

An industry sponsor named Dentsply International, Inc. is the lead sponsor of 7 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:

• NCT03684941: Evaluation of a New Catheter Coating Process for Urinary Catheters Used for Intermittent Catheterization. (Completed, started 2018-08-29)
• NCT02979808: An Open, Qualitative, Prospective, Multicenter Trial of a Novel Transanal Irrigation System in Spinal Cord Injured Patients. (Completed, started 2016-10)
• NCT02071953: Comparative Study of Experimental Dental Adhesive With and Without Phosphoric Acid Pretreatment (Completed, started 2012-04)
• NCT01759537: Study to Evaluate Bone and Gum Dimension Changes Around Dental Implants Placed in Different Positions in Bone. (Completed, started 2012-04)
• NCT01669785: NUPRO Sensodyne Prophylaxis Paste With NovaMin Sensitivity Relief Study (Completed, started 2012-03)

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.

• Dentsply Intl. (291 510(k)s)
• Dentsply Sirona (88 510(k)s)
• Dentsply Interntional (13 510(k)s)
• Dentsply Ceramco (1 510(k)s)
• Dentsply Gendex (1 510(k)s)
• Dentsply Implant (1 510(k)s)
• Dentsply Implants Manufacturing GmbH (1 510(k)s)
• Dentsply Midwest (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Dentsply International, Inc.?

FDA lists 59 510(k) clearances under the applicant name “Dentsply International, Inc.” (first 2001, latest 2016), across 27 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 Dentsply International, Inc.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Dentsply International, Inc. is 70 days.

Which FDA product codes appear under Dentsply International, Inc.?

The most frequent FDA product codes under this applicant name are NHA (Abutment, Implant, Dental, Endosseous, 8); EJT (Alloy, Gold-Based Noble Metal, 5); ELC (Scaler, Ultrasonic, 5).

Next steps

• See all 59 Dentsply International, Inc. clearances with predicates and recalls
• Run predicate analysis for product code NHA, Dentsply International, 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.

All FDA device companies · FDA product code lookup