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Sign in to claim this brandHarry J. Bosworth Co.
US
Last updated May 23, 2026
What Harry J. Bosworth Co. makes
Harry J. Bosworth Co. manufactures dental materials for temporary restorations, including resin-based temporary crowns and bridges, hard and soft denture reliners, and professional denture repair kits. Their portfolio also includes composite and alginate dental impression materials, dental cements, and pit/fissure sealants for cavity protection.
The company’s products are regulated under FDA Class I and Class II designations, with many authorised via 510(k) and UDI listings. These devices are tracked in the FDA’s regulatory databases, ensuring compliance with dental material standards in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of dental devices does Harry J. Bosworth Co. manufacture?
Harry J. Bosworth Co. specialises in dental materials primarily used for temporary restorations and impressions. Their portfolio includes resin-based temporary dental crowns and bridges, hard and soft denture reliners, professional denture repair kits, composite and alginate dental impression materials, dental cements, and pit/fissure sealants. These products are designed to support restorative and prosthetic dental procedures.
Where is Harry J. Bosworth Co. based, and how does that affect its devices?
Harry J. Bosworth Co. is based in the United States. Since the company operates within the US market, its devices are regulated under FDA guidelines. This means their products are authorised through pathways like the 510(k) premarket notification process and must comply with FDA requirements for dental materials, ensuring safety and performance standards are met.
Which regulatory registries or databases list Harry J. Bosworth Co.’s devices?
Harry J. Bosworth Co.’s devices are tracked in the FDA’s regulatory databases, specifically through 510(k) premarket notifications and Unique Device Identifier (UDI) listings. These registries ensure transparency and compliance with US dental material regulations, allowing healthcare providers and regulators to verify the authorised status of individual products.
How are Harry J. Bosworth Co.’s dental devices classified under FDA regulations?
Harry J. Bosworth Co.’s devices fall under FDA Class I and Class II classifications. Class I generally includes low-risk dental materials like some impression materials or sealants, while Class II covers moderate-risk products such as temporary crowns, denture reliners, and professional repair kits. The classification determines the regulatory pathway—Class II often requires a 510(k) submission to demonstrate substantial equivalence to a predicate device.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (306)
Page 7 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Bosworth Liquid Resin Ii | K961200 | FDA 510(k) | Class II | Active |
| Superfil Light & Superfil Bonding System | K811427 | FDA 510(k) | Class II | Active |
| Alumina-Zinc Oxide Powders F And R | K983752 | FDA 510(k) | Class II | Active |
| Bosworth Dentin Resin | K061611 | FDA 510(k) | Class II | Active |
| Bosworth Seal | K051224 | FDA 510(k) | Class II | Active |
| Bosworth Air Polisher | K100731 | FDA 510(k) | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
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FDA Recalls (3)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
The FDA records for Harry J. Bosworth Co. list three recall records initiated between September 23, 2004, and October 13, 2004, all of which are marked as terminated. The recalls involved dental products, including improperly shaped plastic trays that did not conform to patient mouth shapes, a denture repair kit containing the wrong liquid resin, and a kit where the accelerator component hardened in its tube, rendering the impression paste unusable.
AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Oct 13, 2004 | Z-0420-05 | — | terminated | The tray mold was improperly made such that the plastic trays do not conform to the shape of the patient's mouth. |
| Oct 13, 2004 | Z-0421-05 | — | terminated | The accelerator component of the kit hardens in the tube and cannot be used to prepare a workable impression paste. |
| Sep 23, 2004 | Z-0419-05 | — | terminated | The TruRepair denture repair kit contains Trusoft liquid resin instead of the TruRepair liquid resin. If teh Trusoft liquid is used the repair material will not set up. |