Resin, Denture, Relining, Repairing, Rebasing

Device Code: 1124

Product Code(s): EBI

Device Classification Information

• Device Type ID: 1124
• Device Name: Resin, Denture, Relining, Repairing, Rebasing
• Regulation Description: Denture Relining, Repairing, Or Rebasing Resin.
• 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: 872.3760 [🔎]
• FDA Device Classification: Class 2 Medical Device
• Product Code: EBI
• 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

• 4-105 ADA ANSI Standard No. 75 (Reaffirmed 2014)
  Resilient Lining Materials For Removable Dentures, Part 1: Short-Term Materials
• 4-130 ADA ANSI Standard No. 17 (Reaffirmed 2014)
  Denture Base Temporary Relining Resins
• 4-182 ISO 10139-2 Second Edition 2009-08-01
  Dentistry - Soft Lining Materials For Removable Dentures - Part 2: Materials For Long-term Use
• 4-212 ISO 7405 Second Edition 2008-12-15
  Dentistry - Evaluation Of Biocompatibility Of Medical Devices Used In Dentistry [Including: Amendment 1 (2013)]
• 4-214 ISO 10139-1 Second Edition 2005-02-15
  Dentistry - Soft Lining Materials For Removable Dentures - Part 1: Materials For Short-term Use [Including: Technical Corrigendum 1 (2006)]
• 4-232 ISO 20795-1 Second Edition 2013-03-01
  Dentistry - Base Polymers - Part 1: Denture Base Polymers
• 4-233 ISO 20795-2 Second Edition 2013-03-01
  Dentistry - Base Polymers - Part 2: Orthodontic Base Polymers
• 4-234 ADA ANSI Standard No. 139-2012
  Dental Base Polymers
• 4-240 ISO 21563 First Edition 2013-08-15
  Dentistry - Hydrocolloid Impression Materials
• 4-241 ISO 7491 Second Edition 2000-09-01
  Dental Materials - Determination Of Colour Stability
• 4-242 ISO 10139-1 Third Edition 2018-03
  Dentistry - Soft Lining Materials For Removable Dentures - Part 1: Materials For Short-term Use

Total Product Life Cycle

• Device Type ID: 1124
• Device: Resin, Denture, Relining, Repairing, Rebasing
• Product Code: EBI
• FDA Device Classification: Class 2 Medical Device
• Regulation Description: Denture Relining, Repairing, Or Rebasing Resin.
• CFR Regulation Number: 872.3760 [🔎]

Premarket Reviews
Manufacturer	Decision
BISCO, INC.
	SUBSTANTIALLY EQUIVALENT	1
CMP INDUSTRIES LLC
	SUBSTANTIALLY EQUIVALENT	1
DENTCA, INC.
	SUBSTANTIALLY EQUIVALENT	2
GC AMERICA, INC.
	SUBSTANTIALLY EQUIVALENT	1
IVOCLAR VIVADENT AG
	SUBSTANTIALLY EQUIVALENT	1
JUVORA
	SUBSTANTIALLY EQUIVALENT	2
MERZ DENTAL GMBH
	SUBSTANTIALLY EQUIVALENT	1
POLIDENT D.O.O., DENTAL PRODUCTS INDUSTRY
	SUBSTANTIALLY EQUIVALENT	1
PROTECH PROFESSIONAL PRODUCTS, INC.
	SUBSTANTIALLY EQUIVALENT	1
SUN MEDICAL CO., LTD.
	SUBSTANTIALLY EQUIVALENT	1
THE MYERSON COMPANY LTD
	SUBSTANTIALLY EQUIVALENT	1
THERMOPLASTIC COMFORT SYSTEMS, INC.
	SUBSTANTIALLY EQUIVALENT	1
TOKUYAMA DENTAL CORPORATION
	SUBSTANTIALLY EQUIVALENT	1
VOCO GMBH
	SUBSTANTIALLY EQUIVALENT	1
WHIP-MIX CORP.
	SUBSTANTIALLY EQUIVALENT	1
ZEST ANCHORS,LLC ALSO DBA ZEST ANCHORS,INC. AND ZEST ANCHORS
	SUBSTANTIALLY EQUIVALENT	1

Device Problems
Adverse Event Without Identified Device Or Use Problem	11
Patient-Device Incompatibility	4
Inadequate Instructions For Healthcare Professional	2
Use Of Device Problem	1
Device Operates Differently Than Expected	1
Insufficient Information	1
Total Device Problems	20

Recalls
Manufacturer		Recall Class	Date Posted
1	CMP Industries, Llc	II	Oct-30-2018
2	CMP Industries, Llc	II	Jun-29-2016
3	CMP Industries, Llc	II	Jun-29-2016
4	CMP Industries, Llc	II	Mar-09-2016

TPLC Last Update: 2019-04-02 19:48:43