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Found 5 results
510(k) Data Aggregation
K Number
K093014Device Name
AMERICAN DENTAL PRODUCTS SE BONDEASY
Manufacturer
AMERICAN DENTAL PRODUCTS, INC.
Date Cleared
2010-04-16
(199 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
As a Universal Self-Etching Adhesive Bonding System, BONDEASIER SE SYSTEM is indicated to be used as a universal dental adhesive to etch, prime and bond to a tooth structure and meth(acrylic) dental composite.
Device Description
The subject device is a combination of chemical and light-cured self-priming adhesive in a solvent formulation. Bondeasier SE device is not technique sensitive. It requires painting the tooth surface followed by blowing with air to remove the solvent and placing 1-2 layers of 2-3mm of filled light cure Bondeasier SE Adhesive Resin. Lastly, the final curing of each layer of Bondeasier Adhesive Resin is done with a dental curing light.
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K Number
K994368Device Name
AMERICAN DENTAL PRODUCTS CARIES-DETECTOR PLUS
Manufacturer
AMERICAN DENTAL PRODUCTS, INC.
Date Cleared
2000-03-14
(78 days)
Product Code
LFC
Regulation Number
872.1740Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
CARIES INDICATOR PLUS ( CARIES STAIN ) is indicated for detection of caries through the staining of the outer layer of carious dentin.
Device Description
Not Found
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K Number
K991099Device Name
AMERICAN DENTAL PRODUCTS ETCH-DETECT
Manufacturer
AMERICAN DENTAL PRODUCTS, INC.
Date Cleared
1999-06-10
(70 days)
Product Code
EBC
Regulation Number
872.3765Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
USE ETCH-DETECT TO DETECT RESIDUAL DECAY (DENATURED PROTEIN) WHILE ETCHING DENTINE IN THE "TOTAL ETCH" TECHNIQUE.
Device Description
Not Found
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K Number
K973185Device Name
AMERICAN DENTAL PRODUCTS HB-35 DESENSITIZER WITH FLUORIDE
Manufacturer
AMERICAN DENTAL PRODUCTS, INC.
Date Cleared
1997-11-14
(81 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HB-35 DESENSITIZER USE WITH FLUORIDE FOR SENSITIVE
Device Description
Not Found
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K Number
K964133Device Name
AMERICAN DENTAL PRODUCTS HG 35 DESENSITIZER WITH FLUORIDE
Manufacturer
AMERICAN DENTAL PRODUCTS, INC.
Date Cleared
1997-01-09
(86 days)
Product Code
KLE
Regulation Number
872.3200Why did this record match?
Applicant Name (Manufacturer) :
AMERICAN DENTAL PRODUCTS, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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