Sealant, Pit And Fissure, And Conditioner

Device Code: 1118

Product Code(s): EBC

Device Classification Information

• Device Type ID: 1118
• Device Name: Sealant, Pit And Fissure, And Conditioner
• Regulation Description: Pit And Fissure Sealant And Conditioner.
• 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: 872.3765 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EBC
• 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

• 4-149 ADA ANSI Specification No. 39 (Reaffirmed 2011)
  Pit And Fissure Sealants
• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
• 4-222 ISO 6874 Third Edition 2015-09-01
  Dentistry - Polymer-based Pit And Fissure Sealants

Total Product Life Cycle

• Device Type ID: 1118
• Device: Sealant, Pit And Fissure, And Conditioner
• Product Code: EBC
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Pit And Fissure Sealant And Conditioner.
• CFR Regulation Number: 872.3765 [🔎]

Premarket Reviews
Manufacturer	Decision
BISCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
NANOVA BIOMATERIALS INC
	SUBSTANTIALLY EQUIVALENT	1
PAC-DENT INC.
	SUBSTANTIALLY EQUIVALENT	1
PULPDENT CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	1

Recalls
Manufacturer		Recall Class	Date Posted
1	Ivoclar A. G.	II	Nov-04-2015
2	Ivoclar Vivadent, Inc.	II	Feb-29-2016
3	Ultradent Products, Inc.	II	Dec-03-2016

TPLC Last Update: 2019-04-02 19:48:38