Cleared Traditional

K901094 - HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY

K901094 is an FDA 510(k) clearance for HEAD FRAME KIT, manufactured by Grimm & Norton. The device is a Class 2 Dental device with product code JEY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K901094 · Grimm & Norton · Dental device
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Apr 1990
Decision
51d
Days
Class 2
Risk

K901094 is an FDA 510(k) clearance for the HEAD FRAME KIT, ORAL MAXILLOFACIAL SURGERY. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Grimm & Norton (Plainview, US). The FDA issued a Cleared decision on April 27, 1990 after a review of 51 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Grimm & Norton devices

FDA 510(k) Submission Details - K901094

510(k) Number K901094 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1990
Decision Date April 27, 1990
Days to Decision 51 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 127d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JEY Device Classification - Class 2, Special Controls

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 259
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K901094.
LORENZ ULTRA-MICRO TITANIUM OSTEOSYNTHESIS SYSTEM
K910038 · Walter Lorenz Surgical, Inc. · Feb 1991
LUHR MICRO MESH
K901940 · Howmedica Corp. · Sep 1990
LUHR MANDIBULAR COMPRESSION/RECONSTRUCTION PLATES
K901941 · Howmedica Corp. · Sep 1990
STORZ CONTOURED ANATOMICAL PLATING INSTRUMENT
K873926 · Storz Instrument Co. · Feb 1988
DUMBACH TITANIUM MESH IMPLANT SYSTEM
K862532 · Walter Lorenz Surgical, Inc. · Sep 1986
MANUAL SURG. INSTRU. FOR PAULUS TITANIUM SYSTEM
K862505 · Walter Lorenz Surgical, Inc. · Aug 1986