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)
Top companies in EBI
| Company | 510(k)s | Recalls |
|---|---|---|
| Dentsply Intl. | 16 | 0 |
| Heraeus Kulzer, Inc. | 13 | 0 |
| GC America, Inc. | 12 | 0 |
| Cmp Industries, LLC | 5 | 6 |
| Harry J. Bosworth Co. | 8 | 0 |
| Lang Dental Mfg. Co., Inc. | 7 | 1 |
| Voco GmbH | 8 | 0 |
| Vertex-Dental B.V. | 7 | 0 |
| Dentsply Sirona | 6 | 0 |
| Stick Tech , Ltd. | 6 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2025 | STRATASYS LTD TrueDent White, TDM110, Model No. OBJ-09168
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | K220771 |
| Jul 7, 2025 | STRATASYS LTD TrueDent Yellow, TDM140, Model No. OBJ-09169
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | K220771 |
| Jul 7, 2025 | STRATASYS LTD TrueDent Magenta, TDM130, Model No. OBJ-09166
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | K220771 |
| Jul 7, 2025 | STRATASYS LTD TrueDent Cyan, TDM 120, Model No. OBJ-09165
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | K220771 |
| Jul 7, 2025 | STRATASYS LTD TrueDent Clear, TDM 100, Model No. OBJ-09164
Light-curable methacrylate-based resin that enables fabrication of dental appliances Completed |
EBI | K220771 |
| Feb 28, 2024 | GRAPHENANO 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 |
EBI | K220329 |
| Sep 12, 2023 | Keystone 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 |
EBI | None listed |
| Jan 6, 2022 | Envisiontec US Llc FLEXCERA SMILE -a Dental resins for the fabrication of artificial teeth Open, Classified |
EBI | None listed |
| Jan 6, 2022 | Envisiontec US Llc FLEXCERA BASE -a Dental resins for the fabrication of artificial teeth Open, Classified |
EBI | None listed |
| Sep 12, 2018 | CMP 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 |
EBI | None listed |
| Sep 12, 2018 | CMP 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 |
EBI | None listed |
| Jun 29, 2016 | CMP 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 |
EBI | K033020 |
| Apr 28, 2016 | CMP 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 |
EBI | K033020 |
| Apr 28, 2016 | CMP 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 |
EBI | K033020 |
| Mar 9, 2016 | CMP 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 |
EBI | K033020 |
| Jul 20, 2004 | Lang 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 |
EBI | None listed |
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