Cleared Traditional

K904708 - BC 1211 ABUTMENT

K904708 is the FDA 510(k) clearance for BC 1211 ABUTMENT by Minimatic Implant Technology. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 156-day FDA review.

K904708 · Minimatic Implant Technology · Dental device
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Mar 1991
Decision
156d
Days
Class 2
Risk

K904708 is an FDA 510(k) clearance for the BC 1211 ABUTMENT, FIXED TRANSFER PIN, INDIRECT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Minimatic Implant Technology (Deerfield Beach, US). The FDA issued a Cleared decision on March 21, 1991 after a review of 156 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Minimatic Implant Technology devices

Submission Details

510(k) Number K904708 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 16, 1990
Decision Date March 21, 1991
Days to Decision 156 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d slower than avg
Panel avg: 127d · This submission: 156d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 675
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K904708.
BC 1221 BALL OVERDENTURE ATTACHMENT
K904712 · Minimatic Implant Technology · Mar 1991
BC 1203 ABUTMENT TAPERED SHOULDER
K904704 · Minimatic Implant Technology · Mar 1991
BC 1207 ABUTMENT FIXED
K904706 · Minimatic Implant Technology · Mar 1991
BC 1213 HEALING SCREW
K904709 · Minimatic Implant Technology · Mar 1991
BC-1201 CAST ABUTMENT
K904703 · Minimatic Implant Technology · Mar 1991
NOBELPHARMA DRILLING EQUIPMENT DEC 500
K905436 · Nobelpharma USA, Inc. · Mar 1991