International safety notice
Alert 2876 (Technovigilance) Dentsply Indústria e Comércio Ltda AH Plus Sealant Error in the expiration date information on secondary packaging of specific batches.
Brazil / Anvisa · BRA · May 15, 2019
Key facts
| Title | Alert 2876 (Technovigilance) Dentsply Indústria e Comércio Ltda AH Plus Sealant Error in the expiration date information on secondary packaging of specific batches. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade Name: AH Plus Sealant Technical Name: Root Canal Sealant ANVISA registration number: 10186370111 Risk Class: II Affected model: 606.20.110 - AH Plus Kit Introduction Affected lots: Lots on the national market: 350598K 1000 units / 350185K 1000 units / 355238K 483 units / 355097K 1000 units (such lots contain the following lots from the foreign manufacturer: 1707000900 and 1707000899). |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO DENTSPLY INDÚSTRIA E COMÉRCIO LTDA CNPJ 31116239000155 RUA JOSÉ FRANCISCO DE SOUZA 1926 PIRASSUNUNGA SP TEL 11 30462222 EMAIL JULIANASANTOSDENTSPLYSIRONACOM FABRICANTE DO PRODUTO DENTSPLY DETREY GMBH DETREYSTRASSE 1 78467 KONSTANZ ALEMANHA |
| Models | 1707000899, 355238K, 350185K, 606.20.110, 355097K, 350598K, 1707000900, 10186370111 |
| Date | May 15, 2019 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
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About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1