Powder, Porcelain

Device Code: 1187

Product Code(s): EIH

Device Classification Information

• Device Type ID: 1187
• Device Name: Powder, Porcelain
• Regulation Description: Porcelain Powder For Clinical Use.
• 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: 872.6660 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EIH
• 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

• 4-86 ADA ANSI Specification No. 38 2000 (R2015)
  Metal-Ceramic Dental Restorative Systems
• 4-196 ADA ANSI Specification No. 69 - 2010 (Reaffirmed 2015)
  Dental Ceramic
• 4-201 ISO 9693-1 First Edition 2012-02-15
  Dentistry -- Compatibility Testing - Part 1: Metal-ceramic Systems
• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
• 4-223 ISO 6872 Fourth Edition 2015-06-01
  Dentistry - Ceramic Materials
• 4-251 ISO 6872 Fourth Edition 2015-06-01 [including AMENDMENT 1 2018-04]
  Dentistry - Ceramic Materials
• 4-255 ADA ANSI Standard No. 131 - 2015
  Dental CAD/CAM Machinable Zirconia Blanks

Total Product Life Cycle

• Device Type ID: 1187
• Device: Powder, Porcelain
• Product Code: EIH
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Porcelain Powder For Clinical Use.
• CFR Regulation Number: 872.6660 [🔎]

Premarket Reviews
Manufacturer	Decision
3M COMPANY, 3M HEALTH CARE
	SUBSTANTIALLY EQUIVALENT	1
A & D DENTAL INNOVATIONS
	SUBSTANTIALLY EQUIVALENT	1
AMANN GIRRBACH AG
	SUBSTANTIALLY EQUIVALENT	1
AMERICAN MEDICAL SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
AMS
	SUBSTANTIALLY EQUIVALENT	1
BLUE SKY BIO
	SUBSTANTIALLY EQUIVALENT	1
CCRI, INC.
	SUBSTANTIALLY EQUIVALENT	2
CERAMAY GMBH & CO.KG
	SUBSTANTIALLY EQUIVALENT	1
COHO TECHNOLOGY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
CONTINENTAL DENTAL CERAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTAL DIREKT GMBH
	SUBSTANTIALLY EQUIVALENT	3
DENTAL DIREKT OF AMERIKA UG (HAFTUNGSBESCHRAENKT)
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY INTERNATIONAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
DENTSPLY SIRONA
	SUBSTANTIALLY EQUIVALENT	1
DMAX CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
DOCERAM MEDICAL CERAMICS GMBH
	SUBSTANTIALLY EQUIVALENT	1
GC CORP.
	SUBSTANTIALLY EQUIVALENT	3
GENOSS CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
H.C. STARCK CERAMICS GMBH
	SUBSTANTIALLY EQUIVALENT	2
HASS CORP.
	SUBSTANTIALLY EQUIVALENT	1
HEANY INDUSTRIES INC
	SUBSTANTIALLY EQUIVALENT	1
INSTITUT STRAUMANN AG
	SUBSTANTIALLY EQUIVALENT	3
IVOCLAR VIVADENT AG
	SUBSTANTIALLY EQUIVALENT	4
JENSEN INDUSTRIES, INC.
	SUBSTANTIALLY EQUIVALENT	2
KURARAY NORITAKE DENTAL INC.
	SUBSTANTIALLY EQUIVALENT	3
KURARAY NORITAKE DENTAL, INC.
	SUBSTANTIALLY EQUIVALENT	1
LIAONING UPCERA CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
LIAONING UPCERA CO.,LTD
	SUBSTANTIALLY EQUIVALENT	4
METOXIT AG
	SUBSTANTIALLY EQUIVALENT	1
NISSIN-METEC CHINA CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
PRISMATIK
	SUBSTANTIALLY EQUIVALENT	4
PRITIDENTA GMBH
	SUBSTANTIALLY EQUIVALENT	1
RHONDIUM, LTD
	SUBSTANTIALLY EQUIVALENT	1
RIZHAO HUGE DENTAL INDUSTRY CO., LTD
	SUBSTANTIALLY EQUIVALENT	1
SAGEMAX BIOCERAMICS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SHENZHEN XIANGTONG PHOTOELECTRICITY TECHNOLOGY CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
SHOFU DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	3
STRAUMANN
	SUBSTANTIALLY EQUIVALENT	3
TALLADIUM, INC.
	SUBSTANTIALLY EQUIVALENT	4
TANAKA DENTAL
	SUBSTANTIALLY EQUIVALENT	1
THE ARGEN CORPORATION
	SUBSTANTIALLY EQUIVALENT	2
VITA ZAHNFABRIK H. RAUTER GMBH & CO.
	SUBSTANTIALLY EQUIVALENT	1
WHIP-MIX CORP.
	SUBSTANTIALLY EQUIVALENT	1
YETI DENTALPRODUKTE GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZIRKONZAHN GMBH
	SUBSTANTIALLY EQUIVALENT	1
ZIRKONZAHN SRL
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Device Handling Problem	1
Fracture	1
Patient-Device Incompatibility	1
Total Device Problems	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Ivoclar Vivadent, Inc.	II	Oct-04-2016
2	Ivoclar Vivadent, Inc.	II	Jul-27-2015
3	Prismatik Dentalcraft, Inc	II	Sep-27-2016

TPLC Last Update: 2019-04-02 19:49:42