Ivoclar Vivadent, AG: FDA filings under this applicant name

FDA lists 31 510(k) clearances under the applicant name “Ivoclar Vivadent, AG” (first 2004, latest 2022), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 111 days. Since 2017 the median was 145 days, against 138 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

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Ivoclar Vivadent, AG took a median 145 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.

Top product codes

Review panels

• Dental (31)

Most recent Ivoclar Vivadent, AG 510(k) clearances

21 earlier clearances. See the full list in Caduvo.

Recalls

10 product recalls in 2 recall events; 6 initiated in the last five years. Most recent: 2024-04-05.

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 Ivoclar Vivadent, AG is the lead sponsor of 16 device studies on ClinicalTrials.gov (7 active or recruiting). Most recent:

• NCT07212660: A Clinical Trial to Compare the Safety and Performance of Two Different Curing Modes in the Direct Filling Therapy in Deciduous Teeth (Recruiting, started 2025-12-18)
• NCT06615544: Clinical Evaluation of a New Dual-cure Universal Adhesive (Active not recruiting, started 2024-11-04)
• NCT06458738: Clinical Evaluation of a New Printable Denture Base Material (Active not recruiting, started 2024-07-29)
• NCT06369779: Clinical Evaluation of a New Flowable and a New Sculptable Universal Bulk-fill Composite for Direct Restorative Treatment (Active not recruiting, started 2024-05-13)
• NCT06238999: Split-mouth Study of a New Flowable Composite in Non-carious Cervical Lesions (Active not recruiting, started 2024-02-20)

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.

• Ivoclar North America, Inc. (131 510(k)s)
• Ivoclar Vivadent, Inc. (66 510(k)s)
• Ivoclar USA, Inc. (11 510(k)s)
• Ivoclar Vivadent, Agin (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Ivoclar Vivadent, AG?

FDA lists 31 510(k) clearances under the applicant name “Ivoclar Vivadent, AG” (first 2004, latest 2022), across 10 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 Ivoclar Vivadent, AG?

The median time from FDA receipt to decision across 510(k)s cleared under the name Ivoclar Vivadent, AG is 111 days. Since 2017: 145 days, versus 138 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Ivoclar Vivadent, AG?

The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 8); NHA (Abutment, Implant, Dental, Endosseous, 6); EIH (Powder, Porcelain, 5).

Next steps

• See all 31 Ivoclar Vivadent, AG clearances with predicates and recalls
• Run predicate analysis for product code EBF, Ivoclar Vivadent, AG'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.

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