FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

P-10 POSTERIOR FILLING MATERIAL

K Number: K802751 · Decision Nov 12, 1980
Classifications
1
FEI Numbers
187
Registration Numbers
187
Same Product Code
29
Applicant Total
331
Review Days
9

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Basic Information

Device Name
P-10 POSTERIOR FILLING MATERIAL
K Number
K802751
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
872.3670
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
3M Company
Date Received
November 3, 1980
Decision Date
November 12, 1980
Product Code
EBH
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
EBH Material, Impression Tray, Resin

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K222578 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
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