Ring, Teething, Fluid-filled

Device Code: 1283

Product Code(s): KKO

Device Classification Information

Device Type ID1283
Device NameRing, Teething, Fluid-filled
Regulation DescriptionTeething Ring.
Regulation Medical SpecialtyDental
Review PanelDental
Premarket Review Office Of Device Evaluation (ODE)
Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID)
Dental Devices Branch (DEDB)
Submission Type510(K) Exempt
CFR Regulation Number872.5550 [🔎]
FDA Device ClassificationClass 2 Medical Device
Product CodeKKO
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

Total Product Life Cycle

Device Type ID1283
DeviceRing, Teething, Fluid-filled
Product CodeKKO
FDA Device ClassificationClass 2 Medical Device
Regulation DescriptionTeething Ring.
CFR Regulation Number872.5550 [🔎]
TPLC Last Update: 2019-04-02 19:51:17

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