FDA-Device2024-07-03Class II
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.
Dental EZ Group Star Dental Division
Hazard
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
Sold states
US Nationwide distribution.
Affected count
192 units
Manufactured in
1816 Colonial Village Ln, Lancaster, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2178-2024Don't want to check this manually?
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