ENFORCE FRC™
G & H Wire Company, Inc. · Model ENFORCE5 · UDI-DI 10190886000533
Description
TRIAL 5CM A revolutionary new concept in bonded lingual retention and periodontal splinting from G&H® Enforce frc™ incorporates thousands of glass fiber strands bundled together with a pre-impregnated light cure adhesive that allows adaptation directly in the patient's mouth. The intergrated fiber bundle is both malleable and tacky - perfect characteristics for close adaptation and positive retention prior to curing. .032" (.8mm) passive diameter - may be flattened significantly during adaption. The strength and durability of glass fibers combined with filled composite Easy-to-apply chairside method - no pre-adaptation Bonds chemically and mechanically Compatible with all bis-GMA cure composites Metal free & biocompatible Low profile and aesthetic Labial or lingual placement IDEAL FOR MANY APPLICATIONS: Lingual upper & lower retention Diastema retention Segmented treatment adjunct Trauma or periodontal splinting Extraction site maintenance Compliments TAD mechanics
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 that a resin is exp |
| 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 that a resin is exp |
| 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 that a resin is exp |
| 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 that a resin is exp |
| 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 that a resin is exp |
| 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 the Kit and the IFU |
| 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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