Liner, Cavity, Calcium Hydroxide

Device Code: 1202

Product Code(s): EJK

Device Classification Information

• Device Type ID: 1202
• Device Name: Liner, Cavity, Calcium Hydroxide
• Regulation Description: Calcium Hydroxide Cavity Liner.
• 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: 872.3250 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EJK
• 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: 1202
• Device: Liner, Cavity, Calcium Hydroxide
• Product Code: EJK
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Calcium Hydroxide Cavity Liner.
• CFR Regulation Number: 872.3250 [🔎]

Premarket Reviews
Manufacturer	Decision
	SUBSTANTIALLY EQUIVALENT	1
BISCO INC
	SUBSTANTIALLY EQUIVALENT	1
BISCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
SPIDENT CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SYBRON
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Improper Or Incorrect Procedure Or Method	1
Adverse Event Without Identified Device Or Use Problem	1
Appropriate Term/Code Not Available	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Axcentria Pharmaceuticals, LLC	II	Jul-16-2014

TPLC Last Update: 2019-04-02 19:49:55