ELEMENTS OBTURATION UNIT
FDA 510(k) clearance K031664 · decided 2004-04-28
Clearance details
- K-number
- K031664
- Device name
- ELEMENTS OBTURATION UNIT
- Applicant
- Sybron Endo/Analytic
- Decision
- Substantially Equivalent
- Date received
- 2003-05-29
- Decision date
- 2004-04-28
- Days to decision
- 335 days
- Clearance type
- Traditional
- Product code
- EKR
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Redmond, WA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SybronEndo Elements Obturation Unit; REF 973-0322; SN 91-1234; 2005-10; SybronEndo, 1332 S recall (Z-1544-2013) | Ormco/Sybronendo | 2013-06-14 |
| SybronEndo Replacement AC Power Cord, US Elements Obturation; REF 973-0334; SybronEndo, 13 recall (Z-1545-2013) | Ormco/Sybronendo | 2013-06-14 |