ClearanceBrief
Panels › Dental › Product code EBI · Class 2

Resin, Denture, Relining, Repairing, Rebasing

Regulation 872.3760

10510(k)s in 12 months (335 all time)
0recalls in 12 months (16 all time)
10recalls that name a 510(k)
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Top companies in EBI

DateFirm and productCodeLinked 510(k)
Jul 7, 2025STRATASYS LTD
TrueDent White, TDM110, Model No. OBJ-09168 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Completed
EBIK220771
Jul 7, 2025STRATASYS LTD
TrueDent Yellow, TDM140, Model No. OBJ-09169 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Completed
EBIK220771
Jul 7, 2025STRATASYS LTD
TrueDent Magenta, TDM130, Model No. OBJ-09166 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Completed
EBIK220771
Jul 7, 2025STRATASYS LTD
TrueDent Cyan, TDM 120, Model No. OBJ-09165 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Completed
EBIK220771
Jul 7, 2025STRATASYS LTD
TrueDent Clear, TDM 100, Model No. OBJ-09164 Light-curable methacrylate-based resin that enables fabrication of dental appliances
Completed
EBIK220771
Feb 28, 2024GRAPHENANO DENTAL SL
GRAPHENANO DENTAL G-CAM, Product Codes: a) 95 Multichroma 14LB2, REF GC00089; b) 95 Multichroma 24LA2, REF GC00112; c) 95 Multichroma 20LA1, REF GC00130; d) 95 Multichroma 24LC2, REF GC00090; e) 9
Open, Classified
EBIK220329
Sep 12, 2023Keystone Industries
Henry Schein Hard Line Chairside Reline kit-Resilient Acrylic Denture Relining Material KI Item No.: 0921940HS Henry Schein Item No.: 570-0718
Open, Classified
EBINone listed
Jan 6, 2022Envisiontec US Llc
FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth
Open, Classified
EBINone listed
Jan 6, 2022Envisiontec US Llc
FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth
Open, Classified
EBINone listed
Sep 12, 2018CMP Industries, Llc
Technoflux IMPAK Resina lfquida acrilica elastic Curado-Calor Tipo 1, Clase 1 REF: 3748GB. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Terminated
EBINone listed
Sep 12, 2018CMP Industries, Llc
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Terminated
EBINone listed
Jun 29, 2016CMP Industries, Llc
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK PF PINK-FIBERED ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (325cc), Part No. 3314 2) IMPAK ELASTIC ACRYLIC RESIN LIQUID, 11 Ounces (32
Terminated
EBIK033020
Apr 28, 2016CMP Industries, Llc
IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
Terminated
EBIK033020
Apr 28, 2016CMP Industries, Llc
IMPAK Liquid Acrylic Resin sold under the following labels: 1) IMPAK ELASTIC ACRYLIC RESIN LIQUID FOR MOUTHGUARDS & BRUXISM SPLINTS, Contents: 1 Quart (946 ML), REF 3306, Rx ONLY; 2) IMPAK ELASTIC ACR
Terminated
EBIK033020
Mar 9, 2016CMP Industries, Llc
IMPAK ACRYLIC RESIN LIQUID FOR BOTH IMPAK & IMPAK-PF POWDERS 1 qt. size (946 cc), Part Number 3306, and 11 oz. size (325 cc), Part Number 3748. Indicated for relining a denture surface for repairing
Terminated
EBIK033020
Jul 20, 2004Lang Dental Mfg Co, Inc.
Jet Denture Repair Acryulic, fast curing denture repair resin; Lang Dental Manufacturing Co., Inc., Wheeling, IL 60090-0969; product code 1220, 100 gram plastic squeeze bottle and product code 1223 10
Terminated
EBINone listed

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