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Obtura Spartan
OBTURA SPARTAN ENDODONTICS · Model 941-109 · UDI-DI 00816168020640
10
510(k) clearances
3,283
Adverse events (3 deaths)
10
Recalls
107
Facilities
Description
Tip Set of 8 PST 1-8 Contains: 941-101 Tip PST-1 DI# 00816168020565 941-102 Tip PST-2 DI# 00816168020572 941-103 Tip PST-3 DI# 00816168020589 941-104 Tip PST-4 DI# 00816168020596 941-105 Tip PST-5 DI# 00816168020602 941-106 Tip PST-6 DI# 00816168020619 941-107 Tip PST-7 DI# 00816168020626 941-108 Tip PST-8 DI# 00816168020633
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-05-30 | Dental EZ Group Star Dental Division | Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury |
| 2024-05-30 | Dental EZ Group Star Dental Division | Tip holder portion of the scaler tip assembly may have an oversized condition that will not allow the scaler tip to stay seated in the holder may cause injury |
| 2024-03-13 | Electro Medical Systems SA | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not |
| 2024-03-13 | Electro Medical Systems SA | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not |
| 2024-03-13 | Electro Medical Systems SA | Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not |
| 2022-10-14 | Sonendo Inc | Procedure Instruments with erroneous unit carton labels. |
| 2022-10-14 | Sonendo Inc | Procedure Instruments with erroneous unit carton labels. |
| 2019-10-23 | Sonendo Inc | The console would continue to run for extended period when the foot pedal was released. |
| 2016-07-08 | Nakanishi Inc. | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that |
| 2016-07-08 | Nakanishi Inc. | Through an error, the labeling failed to include the symbol or other text indicating that the diamond coated tips were single use only. A contributing factor to this error is that |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.