| Primary Device ID | J014660164550 |
| NIH Device Record Key | 8a3954ed-1d36-411b-85cc-9fad35fcb969 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Starlight pro |
| Version Model Number | 66016455 |
| Catalog Number | 66016455 |
| Company DUNS | 315666321 |
| Company Name | Kulzer GmbH |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| Serial Number | true |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(800)431-1785 |
| customerservice.na@kulzer-dental.com | |
| Phone | +1(800)431-1785 |
| customerservice.na@kulzer-dental.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | J014660164550 [Primary] |
| EBZ | ACTIVATOR, ULTRAVIOLET, FOR POLYMERIZATION |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-02-05 |
| Device Publish Date | 2026-01-28 |
| J014660971700 | Charger unit |
| J014660971690 | Hand piece incl. rechargeable battery |
| J014660969290 | Light guide, 8mm, 45° |
| J014660968300 | Starlight pro |
| J014660573650 | Light guide, 8mm, 70° |
| J014660164550 | Glare shield, orange |