Home › Device types › EBI
Resin, Denture, Relining, Repairing, Rebasing
FDA product code EBI · Class 2 · Dental
10,732
Registered devices
178
Adverse events
16
Recalls
334
510(k) clearances
Devices with this code
Bosworth Dentusil — Harry J Bosworth CompanyCOE-SOFT™ — Gc America Inc.Pink CAD/CAM Disc — POLIDENT d.o.o.POZZI ORTHO LIQUID — AMERICAN TOOTH INDUSTRIESBosworth New Truliner — Harry J Bosworth CompanyPOZZI ORTHO LIQUID — AMERICAN TOOTH INDUSTRIESAvaDent — GLOBAL DENTAL SCIENCE LLCAbro Basic Mono A3 98H13 with step — ZIRKONZAHN SRLProTech Soft Reline — PROTECH PROFESSIONAL PRODUCTS INCO-Cryl Self Curing Acrylic Shade Pink With Glitter X 1 lb — PRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AAesthetic Red — Candulor AGKaradent by TCS — THERMOPLASTIC COMFORT SYSCST — Synca Marketing IncORTHO-JET CRYSTAL LIQUID — LANG DENTAL MANUFACTURING CO., INC.Mizzy Millennium — Keystone IndustriesFreeprint denture pink 385 1000g — DETAX GmbHNOBILIUM — CMP INDUSTRIES LLCHI-I® — FRICKE INTERNATIONAL, INC.HI-I® — FRICKE INTERNATIONAL, INC.Ufi Gel SC — VOCO GmbHNATURE-CRYL® — Gc America Inc.IDODENTINE — UNION DENTAL SAHI-I® — FRICKE INTERNATIONAL, INC.Vertex-Dental BV — Vertex-Dental B.V.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-19 | STRATASYS LTD | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize |
| 2024-01-19 | STRATASYS LTD | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize |
| 2024-01-19 | STRATASYS LTD | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize |
| 2024-01-19 | STRATASYS LTD | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize |
| 2024-01-19 | STRATASYS LTD | Customers unable to use cartridges due to formatting error in expiration date which leads to switching the day with the month. Or, the system will not recognize |
| 2023-10-24 | GRAPHENANO DENTAL SL | Machining error on cams renders the device unusable. |
| 2023-04-10 | Keystone Industries | The Hard Line Chairside Reline Kit (570-0718) (0921940HS) was labeled as Soft Line Chairside Reline Kit (570-0717) (0921250HS) on the outer box. The contents of |
| 2022-01-06 | Envisiontec US Llc | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin |
| 2022-01-06 | Envisiontec US Llc | Manufactured in a non-FDA-registered manufacturing facility and product mislabeled as being of German origin |
| 2018-09-12 | CMP Industries, Llc | Foreign material in product |
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