Medical
Case Study 2
Latex Rubber Dam
Precision Dippings’ partnership with a global manufacturer of premium dental consumables, resulted in the design and production of a new 3-dimensional latex rubber dam for restorative dentistry treatment.
The rubber dam, which has an anatomical frame to match the contours of the mouth, has been developed in two versions – anterior and posterior – to widen the accessible oral area for the dentist.
We worked closely with the company’s R&D team to develop these products, which can be batch produced using production tooling and a high quality, pure natural rubber latex compound.
In use, this innovative rubber dam offers several advantages to both patient and dentist, including:
- Non-contamination and infection control, from saliva, blood and other debris
- Patient protection from accidental aspiration or ingestion
- Much less preparatory work than with conventional dental dams
- Greater access to the operating and working area
- Patient comfort
The rubber dam development process, from prototype to production:
- Detailed drawing received from medical device manufacturer
- Moulds designed to produce the product
- SLA prototype master created from CAD data
- Prototype castings arranged from SLA master
- Prototype products produced for initial customer testing and approval
- Clinical trials were held
- Progression to Production to Levels
- Detailed product specification was agreed
- Manufacturing process was designed and documented in detail
- Batch records were designed, in consultation with the customer, to keep detailed records of each stage of the process
- Batch Release reports were designed to include agreed criteria for final inspection
- Production moulds purchased
- Early phase production commenced
- Progression to production levels of 20,000 units per week
- Product subject to in-process and final inspection
- Product packaged and dispatched with Certificate of Conformity
- Customer Service / Communication
- Partnership approach throughout development of product
- Regular meetings and communication during weekly production