Ring, Teething, Non-fluid Filled

Device Code: 1319

Product Code(s): MEF

Device Classification Information

• Device Type ID: 1319
• Device Name: Ring, Teething, Non-fluid Filled
• Regulation Description: Teething Ring.
• 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: 872.5550 [🔎]
• FDA Device Classification: Class 1 Medical Device
• Product Code: MEF
• GMP Exempt: No
• 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: 1319
• Device: Ring, Teething, Non-fluid Filled
• Product Code: MEF
• FDA Device Classification: Class 1 Medical Device
• Regulation Description: Teething Ring.
• CFR Regulation Number: 872.5550 [🔎]

Recalls
Manufacturer		Recall Class	Date Posted
1	Infantino LLC	II	Apr-01-2014

TPLC Last Update: 2019-04-02 19:51:56