This is the handle body for a dental surgical hand-instrument such as a periotome, Luxator-style elevator, scaler, root-tip pick or bone curette. The handle is investment cast in AISI 316L stainless steel (the surgical grade most commonly specified for dental contact instruments) and then CNC machined to finish the shaft socket, knurled or hand-grip zone, and color-band groove. 316L is preferred for its combination of corrosion resistance to oral fluids, biocompatibility screening data already widely accepted by FDA / EU MDR reviewers, and ease of electropolishing for a smooth, easy-to-clean instrument finish. Investment casting makes it economical to reproduce complex handle geometry — including the integrated grip-flutes that normally require 5-axis machining — in batches of 5,000–100,000 pieces. This part is a hand-held dental instrument handle (Class I medical device), not a permanent implantable.
Material Specifications
- Standard: AISI 316L (UNS S31603 / EN 1.4404 / ASTM A276 Type 316L)
- Heat-treat condition: Annealed / solution-quenched (~ 200 HB)
- Composition reference: ASTM A276; EN 10204 3.1 chemistry certificate
- Bio-compatibility screening: ISO 10993-5 cytotoxicity report available on request
- Magnetic: Non-magnetic in the annealed condition
- Surface REACH / RoHS: compliant per EU MDR requirements
Dimensional Capability & Tolerance
- Weight range: 8 g – 60 g
- Min. wall thickness: 1.0 mm
- As-cast linear tolerance: ISO 8062 CT5 (≈ ±0.10 mm / 25 mm)
- CNC post-machining: ±0.03 mm on shaft socket and color-band groove
- Knurl-zone finish: knurling in-line with CNC; pattern conforming to ASME B94.6
- Inspection: 100% first-article CMM, FAIR per lot; PPAP-style controls when requested
Surface Finish Options
- CNC finished + passivated: Ra 0.8 – 1.6 µm (standard)
- Electropolishing: Ra ≤ 0.4 µm (recommended for dental contact surfaces)
- Satin / matte bead-blast: Ra 0.8 – 3.2 µm (optional, for grip comfort)
- Colour-band anodised marking: optional for instrument family identification
- Laser-etched logo / serial number: optional, with corresponding ink-fill or contrast
Applications
- Periotome / Luxator-style dental elevators
- Dental bone curettes and periosteal elevators
- Dental scaler handles and ultrasonic-scaler grips
- Endodontic hand-instrument handles
- Veterinary dental surgical instruments
Why Choose Ningbo Ruican for This Part
- 17+ years of austenitic stainless casting and CNC finishing — we keep 316L residue-free across casting, finish and passivation to avoid later surface pitting
- Single-piece design vs. handle + collar + tip assembly: stronger, easier to clean, fewer parts to manage
- Flexible low-volume (1,000-piece prototyping) up to 100,000-piece OEM runs on a single casting / machining cell
- Colour-band / laser marking integrated with the CNC cell — one supplier from melted steel to marked handle
Certifications & Regulatory Positioning
- IATF 16949 (valid)
- EN 10204 3.1 chemistry and mechanical certificates — supplied per lot
- FAIR / ISIR per lot, raw-material lot traceability
- REACH / RoHS compliance statement per lot
- Project-level ISO 13485 documentation packages supplied on request; Ningbo Ruican is not an ISO 13485 contract manufacturer
