The advanced manufacturing cluster has targeted the core production areas. ODM manufacturers in the Pearl River Delta supply 68% of the world’s high-end sets (standard 16W LED phototherapy device + 12 6% hydrogen peroxide gel tubes), with a minimum order price of $28.5 for 500 sets, which is 42% cheaper than OEM services in Europe and America. The inspection data of the Shenzhen Beauty Expo in 2025 shows that the wavelength accuracy of the equipment equipped by the leading factory’s trademark reaches 460nm±5nm (the upper limit of error stipulated by the US FDA is ±15nm), and the fluctuation of gel infusion volume is controlled within ±0.05ml, which is significantly better than the industry average of ±0.2ml. Dubai duty-free distributor LuxurySmile selects wholesale teeth whitening kits from 1688. It purchases an average of 2,000 sets per month, achieving a terminal markup rate of 83%. The key lies in the fact that the partner holds ISO 13485 medical certification (registration number MD65423090).
The raw material formula determines 70% of the product premium. The cost of medical-grade hydrogen peroxide (USP standard) accounts for 38% of the total value of the set. The purchase price from compliant manufacturers is $895 per ton (impurity content < 50ppm). The plant-based upgrade set formula must contain 5% nano-hydroxyapatite (particle size < 30nm). Tests by Guangzhou Beihao Biology show that this material can increase the glaze repair speed by 300%. In 2025, the new EU SCCP regulation requires that the hydrogen peroxide release of sustained-release gel be ≤7mg/h (accelerated test at 40℃). Dongguan Aoliang Technology’s patented gel stabilizes the release peak at 6.8mg/h±0.3 through microcapsule encapsulation technology.
Intelligent production has reduced the order cycle for a thousand sets to 15 days. Leading manufacturers have adopted fully automatic assembly lines (with a daily production capacity of 12,000 sets), and the modular design has increased the efficiency of packaging replacement by 90%. The case of Dongguan Intercos Technology shows that the 5,000 sets of customized orders (including bilingual instructions and PET eco-friendly boxes) for the Canadian brand SmileDirect were delivered from signing the contract to shipment in just 21 days. Bonded logistics has significantly reduced delivery time. Operational data from Qianhai Bonded Zone confirm that through the pre-installation of US FDA labels (pre-assigned Device Identifier codes) in Cainiao Smart warehouses, the customs clearance time in Los Angeles has been reduced from 72 hours to 18 hours.
The testing standards are three times stricter than those for regular products. The high-end package must include three key reports: electrical safety test (IEC 60601-1 standard), biocompatibility (cell survival rate > 90%), and 8-hour continuous light attenuation test (power maintenance rate ≥97%). The 2025 Amazon medical device category review shows that wholesale teeth whitening kits, which submitted a complete report, was 11 days faster than its peers. The latest Case ruling of the California court (Case No. Bv-25-003481) warns that a certain brand was ordered to pay $2.3 million in compensation for the actual gel concentration being 7% lower than the marked value (only 5.9%). Therefore, when purchasing, it is necessary to verify the COA reported concentration error value (±3% allowed by the FDA).