DENTSPLY SIRONA INC

Entity profile compiled from public source records

Public Record Profile Registrations: 31 510(k) filings: 0 Recalls: 0

Known Identifiers & Locations

FEI Numbers 1000120733, 1000185904, 1000554802, 1036212, 2515379, 2647456, 3000303964, 3001226627, 3001947560, 3002088145, 3002806429, 3002806793, 3002807009, 3002808442, 3002809338, 3003136642, 3003719498, 3003756493, 3003762341, 3003999430, 3004203816, 3004724816, 3004884150, 3006186796, 3006553489, 3007362683, 3009632672, 3011824442, 3013111692, 3017619720, 3029904428
Owner Operator Numbers 2511302
Locations Covered BADIA POLESINE (RO) Rovigo, IT; BALLAIGUES Vaud, CH; BAR LEV INDUSTRIAL PARK Northern, IL; BENSHEIM Hesse, DE; Bensheim Hesse, DE; Berlin Brandenburg, DE; HANAU Hesse, DE; Hanau Hesse, DE; Hasselt Limburg, BE; Johnson City, TN, US; KONSTANZ Baden-Wurttemberg, DE; Kahramankazan Ankara, TR; Lancaster, PA, US; Las Piedras, PR, US; MILFORD, DE, US; MOLNDAL Vastra Gotaland, SE; MUNICH Bavaria, DE; Mexicali Baja California, MX; Molndal Vastra Gotaland, SE; PIRASSUNUNGA Sao Paulo, BR; RICHARDSON, TX, US; Rosbach V.D.H. Hesse, DE; ST. EGREVE Isere, FR; Sarasota, FL, US; Sevenum Limburg, NL; TEDA Tianjin, CN; Waltham, MA, US; York, PA, US; Zurich, CH

Registered Establishments (31)

Registration # Establishment Name Location Establishment Type(s) Action
1036212 Dentsply Sirona Orthodontics Inc. Sarasota, FL, US Develop Specifications But Do Not Manufacture At This Facility View Details
1222802 DENTSPLY IH Inc. Waltham, MA, US Manufacture Medical Device View Details
1649995 Dentsply Sirona Orthodontics Inc. RICHARDSON, TX, US Develop Specifications But Do Not Manufacture At This Facility View Details
2320721 TULSA DENTAL PRODUCTS LLC Johnson City, TN, US Repack or Relabel Medical Device,Manufacture Medical Device View Details
2424472 DENTSPLY LLC York, PA, US Develop Specifications But Do Not Manufacture At This Facility View Details
2515379 DENTSPLY LLC MILFORD, DE, US Manufacture Medical Device View Details
2647456 DS REP B.V. Las Piedras, PR, US Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3000303964 DENTSPLY DENTAL (TIANJIN) CO., LTD. TEDA Tianjin, CN Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3001226627 RECHERCHES TECHNIQUES DENTAIRES (R.T.D.) ST. EGREVE Isere, FR Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3003136642 OraMetrix GmbH Berlin Brandenburg, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3003756493 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3004203816 MIS Implants Technologies Ltd. BAR LEV INDUSTRIAL PARK Northern, IL Manufacture Medical Device View Details
3004884150 DENTSPLY SIRONA INC York, PA, US Complaint File Establishment per 21 CFR 820.198 View Details
3006186796 DENTSPLY NORTH AMERICA LLC Lancaster, PA, US Repack or Relabel Medical Device View Details
3006553489 Wellspect Medikal A.S. Kahramankazan Ankara, TR Sterilize Medical Device for Another Party (Contract Sterilizer),Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3007362683 DENTSPLY Implants N.V. Hasselt Limburg, BE Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device View Details
3009632672 Wellspect Healthcare Molndal Vastra Gotaland, SE Sterilize Medical Device for Another Party (Contract Sterilizer) View Details
3011824442 DENTSPLY IH BV Sevenum Limburg, NL Export Device to the United States But Perform No Other Operation on Device View Details
3013111692 Dentsply Implants Manufacturing GmbH Hanau Hesse, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3017619720 Orthodental S.A. de C.V. Mexicali Baja California, MX Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
3029904428 Zetta25 AG Zurich, CH Manufacture Medical Device View Details
8010638 DENTSPLY DETREY GmbH KONSTANZ Baden-Wurttemberg, DE Manufacture Medical Device View Details
8031010 MAILLEFER INSTRUMENTS HOLDING SARL BALLAIGUES Vaud, CH Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
8040288 DENTSPLY INDUSTRIA E COMERCIO LTDA PIRASSUNUNGA Sao Paulo, BR Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
9611053 VDW GMBH MUNICH Bavaria, DE Develop Specifications But Do Not Manufacture At This Facility View Details
9612468 Dentsply IH AB MOLNDAL Vastra Gotaland, SE Develop Specifications But Do Not Manufacture At This Facility View Details
9612618 DEGUDENT GMBH Rosbach V.D.H. Hesse, DE Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
9614794 ZHERMACK S.P.A. BADIA POLESINE (RO) Rovigo, IT Manufacture Medical Device for Another Party (Contract Manufacturer) View Details
9614977 SIRONA DENTAL SYSTEMS GMBH BENSHEIM Hesse, DE Export Device to the United States But Perform No Other Operation on Device View Details
9681199 DEGUDENT GMBH HANAU Hesse, DE Manufacture Medical Device View Details
9681851 Sirona Dental Systems GmbH Bensheim Hesse, DE Develop Specifications But Do Not Manufacture At This Facility View Details

510(k) Premarket Notifications (0)

No 510(k) notifications found for this entity.

FDA Recall History (0)

No recall records found for this entity.

Profile Disclaimer

AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.

Account Required Full available specs will require a free AvaSpecs account.