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510(k) Data Aggregation
K Number
K151748Device Name
Clean & More
Manufacturer
3M DEUTSCHLAND GMBH
Date Cleared
2016-03-11
(256 days)
Product Code
PIP, LBH
Regulation Number
872.6080Why did this record match?
Product Code :
PIP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
· Professional cleaning of teeth: Removal of subgingival and supragingival plaque-biofilm and stains
· Professional cleaning of teeth including patients with dentin hypersensitivity
· Treatment of dentin hypersensitivity by blockage of the dentin tubules
· Can also be used in the presence of fixed orthodontic devices (brackets), restorative and prosthetic materials, and implants
· For maintenance in periodontitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
· For maintenance in perimplantitis therapy after completion of initial treatment - when using standard devices - for gingival pockets up to 5 mm in depth
Device Description
Clean & More is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning.
Clean & More is a prophylactic powder for gentle and professional sub- and supragingival cleaning of teeth, including the removal of plaque-biofilm and stains, using commercially available air polishing devices.
Clean & More is a glycine based air polishing powder containing functionalized tri-calcium phosphate, a substance which blocks open dentin tubules on the tooth surface, thereby contributing to a reduction in dentin hypersensitivity.
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K Number
K140684Device Name
CLINPRO PROPHY POWDER
Manufacturer
3M DEUTSCHLAND GMBH
Date Cleared
2014-10-24
(220 days)
Product Code
PIP
Regulation Number
872.6080Why did this record match?
Product Code :
PIP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- Removal of subgingival and supragingival plaque; can also be used in the presence of permanent orthodontic apparatus (brackets) and implants
- For maintenance in periodontitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
- For maintenance in periimplantitis therapy after completion of initial treatment, for gingival pockets up to 5 mm in depth only
Calculi and tartar cannot be removed with Clinpro Prophy Powder.
Device Description
Clinpro TM Prophy Powder is classified as airbrush (21 C.F.R. § 872.6080) because it is a powder to be used with air polishing devices in the professional tooth cleaning. As the predicate devices Air-N-Go® Perio Powder (K110379) and Air-Flow® Perio Powder (K092289), Clinpro Prophy Powder is a glycine based air polishing powder to be used with air polishing devices in the professional tooth cleaning.
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