510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Zirkonzahn SRL

Gais Bolzano, IT

ZIRKONZAHN SRL appears in FDA device records in Gais Bolzano, IT. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
11
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 11 510(k) clearances for Zirkonzahn SRL between 2006 and 2023. The busiest year on record is 2018, with 2. The most recent is 2023, with 1.

Clearances by year, as a table
510(k) clearance decisions for Zirkonzahn SRL, by decision year
YearClearances
20061
20141
20151
20182
20192
20201
20211
20221
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K232691PolibondEBISubstantially Equivalent
K213722ICE Ceramics, ICE Stains, FrescoEIHSubstantially Equivalent
K203765ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-TrayLLZSubstantially Equivalent
K200676ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPAEBGSubstantially Equivalent
K190518Color Liquid, Vita LiquidEIHSubstantially Equivalent
K183304Prettau, ICE, Z-White zirconia blanksEIHSubstantially Equivalent
K180562TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUTEBGSubstantially Equivalent
K181484Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral TissueEBFSubstantially Equivalent
K151490PRETTAU ANTERIOR T0EIHSubstantially Equivalent
K132230ICE ZIRKON TRANSLUZENTEIHSubstantially Equivalent
K061851ZIRKONZAHN ICEEIHSubstantially Equivalent

Registered establishments

FDA registered establishments for Zirkonzahn SRL, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30059049063005904906ZIRKONZAHN SRLVIA AN DER AHR 7, Gais Bolzano 39030 IT2026and 8 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain