Home › Device types › EBI
Resin, Denture, Relining, Repairing, Rebasing
FDA product code EBI · Class 2 · Dental
10,783
Registered devices
179
Adverse events
16
Recalls
335
510(k) clearances
Devices with this code
Denture Gingiva Basic Mono Pink 125H40 — ZIRKONZAHN SRLHI-I® — FRICKE INTERNATIONAL, INC.Vertex-Dental BV — Vertex-Dental B.V.Vertex-Dental BV — Vertex-Dental B.V.Abro Basic Mono Bleach 95H13 — ZIRKONZAHN SRLAbro Basic Mono A2 98H24 — ZIRKONZAHN SRLSPRUZZO GLITTER — AMERICAN TOOTH INDUSTRIESAvaDent — GLOBAL DENTAL SCIENCE LLCBASIS FLOW II — YAMAHACHI DENTAL MFG.,CO.Karadent by TCS — THERMOPLASTIC COMFORT SYSAbro Basic Mono B3 98H34 with step — ZIRKONZAHN SRLHygenic — COLTENE/WHALEDENT INCG-CAM — GRAPHENANO DENTAL SL.Vitacrilic® — FRICKE INTERNATIONAL, INC.Hygenic — COLTENE/WHALEDENT INCNOBILIUM — CMP INDUSTRIES LLCAbro Basic Mono B2-B3 98H18 with step — ZIRKONZAHN SRLAbro Basic Mono B2 106H39 — ZIRKONZAHN SRLBASIS HI — YAMAHACHI DENTAL MFG.,CO.Perflex AcryFree — PERFLEX LTDAbro Basic Multistratum A1-A2 95H12 — ZIRKONZAHN SRLMolloplast B one free relining — DETAX GmbHG-CAM — GRAPHENANO DENTAL SL.ORTHO-JET LIQUID — LANG DENTAL MANUFACTURING CO., INC.
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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