ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW— 510(k) K881253
Substantially EquivalentDentalez Group
FDA 510(k) clearance K881253 for ROTORY SCALER SWIVEL IMPROVEMENT FEATURE, TITAN SW, Substantially Equivalent on 1988-04-21. Applicant: Dentalez Group. Device class: 2.
Clearance details
- Applicant
- Dentalez Group
- Product code
- Code ELC
- Device class
- Class 2
- Regulation
- 21 CFR 872.4850
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Lancaster, PA, US
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Adverse events under product code ELC
product code ELC- Malfunction
- 1,255
- Total
- 1,255
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K881253
K-number listed on FDA's recall record- Z-2177-2024 — Titan Scaler Tip - Perio Model/Catalog Number: 261669 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
- Z-2178-2024 — Titan Blis-Sonic Scaler packaged with the Titan Scaler Tip - Perio (part number 261669) (1) P/N 264563 (2) P/N 264565 The scaler tip is used with an air drive scaler for subgingival scaling and fine access. The Perio tip is used for lingual supragingival scaling of mandibular incisors and deep local pockets.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K881253.
Data sourced from openFDA. This site is unofficial and independent of the FDA.