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510(k) Data Aggregation
K Number
K033044Device Name
DREAM CLEANSE S SCALER, DREAM COMPACT S SCALER
Manufacturer
AMERICAN GREEN DENT. MFG, INC.
Date Cleared
2004-12-21
(449 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN GREEN DENT. MFG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dream Cleans "S" Scaler and Dream Compact "S" scalers are hand held ultrasonic instruments used for removal of supragingival and subgingival calculus and stains from teeth. They are also used for periodontal scaling and root planing.
Device Description
hand held ultrasonic instruments
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K Number
K033045Device Name
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
Manufacturer
AMERICAN GREEN DENT. MFG, INC.
Date Cleared
2003-12-23
(85 days)
Product Code
EJH
Regulation Number
872.3710Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN GREEN DENT. MFG, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
"DREAMBOND" (Ceramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
"DREAMCAST CHROME" (Partial Denture Dental Casting Alloy) is for the use in dental laboratories, suitable for preparation of removable dental applications.
"DREAMCAST V" (Cramic dental casting Alloy) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
"DREAM FLEXICAST"" (Partial Denture Cobalt Base Alloy") is for the use in dental laboratories. suitable for preparation of removable dental applications.
"DREAM LITHECAST" (Ceramic dental casting Alloy Nickel & Beryllium Free) is used in dental laboratories, suitable for fabrication of metal-ceramic dental restorations.
Device Description
General:- Dental Alloys
Specific :- "DREAMBOND""DREAMCAST CHROME" "DREAMCAST V" "DREAM FLEXICAST" "DREAM LITHECAST"
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