Pin, Retentive And Splinting, And Accessory Instruments

Device Code: 1125

Product Code(s): EBL

Device Classification Information

Device Type ID1125
Device NamePin, Retentive And Splinting, And Accessory Instruments
Regulation DescriptionRetentive And Splinting Pin.
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 Number872.3740 [🔎]
FDA Device ClassificationClass 1 Medical Device
Product CodeEBL
GMP ExemptNo
Summary MREligible
Implanted DeviceNo
Life Support DeviceNo
Third Party Review Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

Device Type ID1125
DevicePin, Retentive And Splinting, And Accessory Instruments
Product CodeEBL
FDA Device ClassificationClass 1 Medical Device
Regulation DescriptionRetentive And Splinting Pin.
CFR Regulation Number872.3740 [🔎]
TPLC Last Update: 2019-04-02 19:48:44

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