FDA 510(k) FDA class 2 Substantially Equivalent 🇬🇷 Greece

DMP SINGLE BONDING

K Number: K102254 · Decision Nov 23, 2010
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
418
Applicant Total
6
Review Days
105

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Basic Information

Device Name
DMP SINGLE BONDING
K Number
K102254
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3200
Medical Specialty
Dental
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Dmp, Ltd.
Date Received
August 10, 2010
Decision Date
November 23, 2010
Product Code
KLE
Advisory Committee
Dental
Review Advisory Committee
DE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
KLE Agent, Tooth Bonding, Resin

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (KLE), ordered by most recent decision date.

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Other Clearances by Dmp, Ltd.

K Number Device Name
K121915 BRIGHT RESTORATIVE MATERIALS
K102836 BONASIL A+ IMPRESSION MATERIALS
K102252 DMP PIT & FISSURE SEALANT
K102255 DMP ETCHING GEL
K102257 NANOCERAM- BRIGHT