Coating, Filling Material, Resin

Device Code: 1119

Product Code(s): EBD

Device Classification Information

• Device Type ID: 1119
• Device Name: Coating, Filling Material, Resin
• Regulation Description: Coating Material For Resin Fillings.
• 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)
• CFR Regulation Number: 872.3310 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EBD
• 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

• 4-212 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: 1119
• Device: Coating, Filling Material, Resin
• Product Code: EBD
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Coating Material For Resin Fillings.
• CFR Regulation Number: 872.3310 [🔎]

Premarket Reviews
Manufacturer	Decision
DREVE DENTAMID GMBH
	SUBSTANTIALLY EQUIVALENT	1
GC CORP.
	SUBSTANTIALLY EQUIVALENT	1
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1

TPLC Last Update: 2019-04-02 19:48:39