Tray, Impression, Preformed

Device Code: 1178

Product Code(s): EHY

Device Classification Information

• Device Type ID: 1178
• Device Name: Tray, Impression, Preformed
• Regulation Description: Preformed Impression Tray.
• Regulation Medical Specialty: Dental
• Review Panel: Dental
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Dental Devices Branch (DEDB)
• Submission Type: 510(K) Exempt
• CFR Regulation Number: 872.6880 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: EHY
• GMP Exempt: Yes
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

Total Product Life Cycle

• Device Type ID: 1178
• Device: Tray, Impression, Preformed
• Product Code: EHY
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Preformed Impression Tray.
• CFR Regulation Number: 872.6880 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Implant Direct Sybron Manufacturing, LLC	II	Jun-23-2016

TPLC Last Update: 2019-04-02 19:49:27