Denture, Plastic, Teeth

Device Code: 1244

Product Code(s): ELM

Device Classification Information

• Device Type ID: 1244
• Device Name: Denture, Plastic, Teeth
• Regulation Description: Preformed Plastic Denture Tooth.
• 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: 872.3590 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: ELM
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: No
• Life Support Device: No
• Third Party Review: Eligible For Accredited Persons Expansion Pilot Program

Recognized Standards

• 4-151 ISO 22112 First Edition 2005-11-01
  Dentistry -- Artificial Teeth For Dental Prostheses
• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]

Total Product Life Cycle

• Device Type ID: 1244
• Device: Denture, Plastic, Teeth
• Product Code: ELM
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Preformed Plastic Denture Tooth.
• CFR Regulation Number: 872.3590 [🔎]

Premarket Reviews
Manufacturer	Decision
IVOCLAR VIVADENT, INC.
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Patient-Device Incompatibility	1
Adverse Event Without Identified Device Or Use Problem	1
Total Device Problems	2

TPLC Last Update: 2019-04-02 19:50:34