| Primary Device ID | D867CLMB101 |
| NIH Device Record Key | cc8366a6-01c4-4c6e-a9cc-7adf1021ad5c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Cusp-Lok |
| Version Model Number | MB |
| Catalog Number | CLMB10 |
| Company DUNS | 804495695 |
| Company Name | Xemax Surgical Products Inc |
| Device Count | 10 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D867CLMB10 [Primary] |
| HIBCC | D867CLMB101 [Unit of Use] |
| EJF | Bracket, Metal, Orthodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
[D867CLMB101]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-09-19 |
| Device Publish Date | 2022-09-09 |
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| D867CLTS1 | Orthodontic bracket with chain |
| D867CLMBLP101 | Orthodontic bracket with chain |
| D867CLMBLP051 | Orthodontic bracket with chain |
| D867CLMB101 | Orthodontic bracket with chain |
| D867CLMB051 | Orthodontic bracket with chain |
| D867CLIMLP101 | Orthodontic bracket with chain |
| D867CLIMLP051 | Orthodontic bracket with chain |
| D867CLIMCLP101 | Orthodontic bracket with chain |
| D867CLIMCLP051 | Orthodontic bracket with chain |
| D867CLIMC101 | Orthodontic bracket with chain |
| D867CLIM101 | Orthodontic bracket with chain |
| D867CLIM051 | Orthodontic bracket with chain |
| D867CLILP101 | Orthodontic bracket with chain |
| D867CLILP51 | Orthodontic bracket with chain |
| D867CLIIMLP101 | Orthodontic bracket with chain |
| D867CLIIMLP051 | Orthodontic bracket with chain |
| D867CLIIMCLP101 | Orthodontic bracket with chain |
| D867CLIIMCLP051 | Orthodontic bracket with chain |
| D867CLIIMC101 | Orthodontic bracket with chain |
| D867CLIIM101 | Orthodontic bracket with chain |
| D867CLIIM051 | Orthodontic bracket with chain |
| D867CLIILP101 | Orthodontic bracket with chain |
| D867CLIILP051 | Orthodontic bracket with chain |
| D867CLII101 | Orthodontic bracket with chain |
| D867CLII051 | Orthodontic bracket with chain |
| D867CLI101 | Orthodontic bracket with chain |
| D867CLI051 | Orthodontic bracket with chain |
| D867CLCMR101 | Orthodontic bracket with chain |
| D867CLCMLP101 | Orthodontic bracket with chain |
| D867CLCMLP051 | Orthodontic bracket with chain |
| D867CL360101 | Orthodontic bracket with chain |
| D867CL360051 | Orthodontic bracket with chain |