| 1 | Supplier 01 | 0.022 in0.018 in | Medical-grade austenitic stainless steel, commonly 316L or an equivalent corrosion-resistant alloy. | Roth prescription geometry, color-coded identification marks, rounded tie wings, and optional single or twin bracket configurations. | Precision progressive stamping, CNC finishing, deburring, polishing, ultrasonic cleaning, and passivation. | ISO 13485 quality-management system; ISO 14971 risk-management principles; applicable Chinese medical-device requirements. | Slot dimensions, base contour, bracket height, tie-wing integrity, surface roughness, corrosion resistance, and lot traceability. |
| 2 | Supplier 02 | 0.022 in0.018 in | Stainless steel with optional nickel-reduced or nickel-free alloy selections for sensitivity-conscious applications. | Low-profile design, smooth rounded edges, laser-etched tooth-position marks, and compatibility with standard orthodontic archwires. | Metal forming, micro-milling, laser marking, vibratory polishing, cleaning, passivation, and visual inspection. | ISO 13485; ISO 10993 biological-evaluation framework where applicable; documented process-validation procedures. | Dimensional inspection by optical measurement, material composition verification, weld or joint inspection, and packaging seal checks. |
| 3 | Supplier 03 | 0.022 in0.018 in | 316L stainless steel for metal brackets; alumina-based ceramic available for selected aesthetic configurations. | Roth torque and angulation prescriptions, reinforced tie wings, high-contrast identification marks, and optional hook designs. | Precision stamping for metal parts; ceramic injection molding, sintering, glazing, laser marking, and final assembly. | ISO 13485; ISO 20417 information requirements for medical devices; applicable labeling and technical-documentation rules. | Bracket orientation, torque and angulation verification, ceramic surface inspection, bond-base consistency, and pull-strength testing. |
| 4 | Supplier 04 | 0.022 in0.018 in | Corrosion-resistant stainless steel, with ceramic or polycrystalline alumina options for aesthetic product lines. | Compact profile, anatomically contoured bonding base, smooth slot entry, and available premolar and molar hook options. | Stamping, precision coining, slot calibration, electropolishing, ceramic sintering, adhesive-base treatment, and cleaning. | ISO 13485; ISO 15223-1 symbol use where relevant; manufacturing controls aligned with Chinese medical-device regulations. | Slot gauge testing, base-area measurement, edge-radius inspection, surface cleanliness, and batch-to-batch consistency review. |
| 5 | Supplier 05 | 0.022 in0.018 in | Medical-grade stainless steel with optional gold-colored surface finishing for identification or aesthetic preference. | Standard Roth prescription, color-coded or laser-marked tooth identification, contoured bonding pad, and replaceable-position formats. | Cold forming, CNC slot finishing, laser marking, polishing, passivation, surface-treatment control, and ultrasonic washing. | ISO 13485; ISO 14971; documented calibration, nonconforming-product control, corrective-action, and supplier-audit procedures. | Coating adhesion where applicable, slot accuracy, corrosion testing, marking legibility, bonding-base profile, and sterilization-pack compatibility. |
| 6 | Supplier 06 | 0.022 in0.018 in | Stainless steel for conventional brackets; polycrystalline alumina or zirconia-based ceramic for selected aesthetic models. | Low-friction slot finish, rounded tie wings, high visibility of tooth-position marks, and options for standard or extended hooks. | Metal stamping and milling; ceramic molding, high-temperature sintering, precision grinding, polishing, and inspection. | ISO 13485; ISO 10993 evaluation principles for patient-contacting materials; validated inspection and release procedures. | Friction-related surface checks, dimensional tolerance, ceramic crack inspection, hook strength, bond-base uniformity, and cleanliness. |
| 7 | Supplier 07 | 0.022 in0.018 in | 316L or comparable medical-grade stainless steel with passivated surfaces and optional nickel-reduced material selection. | Roth prescription options, smooth slot corners, identification dots, ergonomic tie-wing shape, and standard archwire compatibility. | Multi-stage stamping, fine blanking, slot broaching, deburring, passivation, automated optical inspection, and packaging. | ISO 13485; ISO 9001 may support the broader manufacturing system; applicable product registration and labeling controls. | Automated optical dimensional inspection, chemical composition checks, surface defects, tie-wing alignment, and package integrity. |
| 8 | Supplier 08 | 0.022 in0.018 in | Stainless steel, ceramic, and selected polymer components for auxiliary identification or packaging applications. | Standard Roth prescription, anatomical bonding contours, rounded edges, optional hooks, and mixed-material product availability. | Metal forming, ceramic sintering, polymer injection molding for accessories, laser marking, cleaning, and assembly inspection. | ISO 13485; ISO 14971; documented design-change control, process validation, complaint handling, and traceability procedures. | Material identity, dimensional conformity, ceramic integrity, component fit, marking accuracy, and finished-goods sampling inspection. |
| 9 | Supplier 09 | 0.022 in0.018 in | Passivated stainless steel with optional ceramic or tooth-colored aesthetic bracket variants. | Roth torque and angulation values, smooth facial profile, broad bonding base, clear orientation marks, and standard hook choices. | Precision stamping, CNC calibration, electropolishing, ceramic forming where applicable, ultrasonic cleaning, and final inspection. | ISO 13485; applicable Chinese standards for medical-device production, inspection, packaging, and product identification. | Torque and angulation checks, slot-gauge verification, base-contour inspection, surface cleanliness, and batch-release documentation. |
| 10 | Supplier 10 | 0.022 in0.018 in | Medical-grade stainless steel, with optional alumina ceramic brackets and nickel-reduced material programs. | Roth prescription configurations, color-coded identification, smooth slot surfaces, anatomical bases, and customizable packaging. | Cold forming, precision machining, laser marking, passivation, ceramic sintering, ultrasonic cleaning, and controlled packaging. | ISO 13485; ISO 14971; ISO 10993 assessment principles where relevant; supplier qualification and batch-traceability controls. | Slot and base dimensions, surface-finish assessment, marking durability, bond-base consistency, corrosion resistance, and final sampling. |