| Roth prescription compatibility | The product should be manufactured according to the requested Roth prescription chart, including tip, torque, angulation, and rotation values. | Request a complete prescription chart and compare it with the values used in the clinician’s treatment system. | Mandatory match |
| Available slot sizes | Common orthodontic bracket slot options include 0.018 in and 0.022 in. The selected size must match the treatment protocol. | Confirm slot size, tolerance, edge design, and whether the same prescription is available in both slot options. | Mandatory match |
| Bracket material | Metal brackets are commonly produced from medical-grade stainless steel, often using corrosion-resistant steel grades such as 17-4 PH or an equivalent specification. | Ask for the material grade, material certificate, corrosion-resistance information, and surface-treatment details. | Document required |
| Base design and retention | A reliable base should provide consistent mechanical retention and adequate bonding area without excessive sharp edges. | Evaluate base pattern, dimensions, weld quality, edge finishing, and bonding performance through samples or test reports. | Sample testing |
| Marking and identification | Clear tooth identification, quadrant marking, and left/right orientation reduce placement errors during clinical use. | Check marking contrast, durability after sterilization, readability under clinical lighting, and packaging traceability. | High priority |
| Dimensional consistency | Consistent slot dimensions, bracket height, tie-wing geometry, and prescription values are essential for predictable appliance performance. | Request dimensional inspection records, sampling plans, calibration records, and batch-to-batch comparison data. | Critical quality check |
| Manufacturing quality system | A documented quality-management system should control incoming materials, production, inspection, nonconformities, and corrective actions. | Verify the scope and validity of ISO 13485 certification or an equivalent medical-device quality system. | Required for long-term supply |
| Regulatory documentation | Regulatory requirements vary according to the destination market and product classification. | Request the applicable declaration, technical file summary, test reports, labeling information, and authorized-market documentation. | Market-specific verification |
| Biocompatibility and safety | Materials contacting the oral environment should be evaluated according to the applicable medical-device biocompatibility requirements. | Ask for relevant biological-evaluation or biocompatibility evidence and confirm that it applies to the finished product. | Required evidence |
| Sterilization status | Many orthodontic brackets are supplied non-sterile and sterilized by the clinic according to validated procedures; the product label must state the correct status. | Confirm whether products are sterile or non-sterile, compatible sterilization methods, and packaging integrity requirements. | Label and process check |
| Sample and pilot-order policy | A professional supplier should support pre-purchase samples, prescription confirmation, and pilot-batch evaluation. | Compare sample fees, sample lead time, available configurations, and whether production follows the approved sample. | Strong selection advantage |
| Minimum order quantity | MOQ differs by configuration, packaging format, customization level, and whether the item is standard or made to order. | Obtain written MOQ terms for each prescription, slot size, tooth number, and packaging option. | Compare total purchasing cost |
| Lead time and capacity | Lead time depends on stock availability, order quantity, customization, inspection, and export documentation. | Request standard and customized lead times, monthly capacity, production scheduling method, and delay-notification procedure. | Measure delivery reliability |
| Packaging and traceability | Packaging should protect small components from contamination, mixing, mechanical damage, and loss during transport. | Check lot number, manufacturing date, quantity, prescription, slot size, tooth identification, and carton labeling. | Required for recall control |
| Quality claims and warranty | Clear procedures should exist for defective brackets, missing components, incorrect prescriptions, and shipping damage. | Compare claim-response time, replacement policy, required evidence, credit terms, and corrective-action process. | Assess before contracting |
| Overall supplier score | A reliable selection should prioritize prescription accuracy, regulatory evidence, dimensional consistency, traceability, and repeatable delivery over price alone. | Use a weighted scorecard: product conformity 30%, quality and regulatory evidence 25%, samples 15%, delivery 15%, service 10%, price 5%. | Select the highest verified score |