FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

ENDOSSEOUS IMPLANTS

K Number: K904236 · Decision Nov 27, 1991
Classifications
1
FEI Numbers
324
Registration Numbers
324
Same Product Code
1545
Applicant Total
2
Review Days
436

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Basic Information

Device Name
ENDOSSEOUS IMPLANTS
K Number
K904236
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
872.3640
Medical Specialty
Dental
Decision
Substantially Equivalent
Applicant
Attachments Intl., Inc.
Date Received
September 17, 1990
Decision Date
November 27, 1991
Product Code
DZE
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
DZE Implant, Endosseous, Root-Form

Similar 510(k) Clearances

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

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Other Clearances by Attachments Intl., Inc.

K Number Device Name
K900099 THE O-RING SYSTEM - ORS