| Primary Device ID | 04589551384082 |
| NIH Device Record Key | 7c51691c-61a9-477f-b748-705b91535869 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Straumann SGL80M |
| Version Model Number | Straumann SGL80M |
| Company DUNS | 690710546 |
| Company Name | NAKANISHI INC. |
| 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 | true |
| 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 |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 04589551384082 [Direct Marking] |
| GS1 | 04589551393381 [Primary] |
| EBW | Controller, foot, handpiece and cord |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[04589551384082]
Moist Heat or Steam Sterilization
[04589551384082]
Moist Heat or Steam Sterilization
[04589551384082]
Moist Heat or Steam Sterilization
[04589551384082]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-01-12 |
| Device Publish Date | 2026-01-03 |
| 04589551393374 - Straumann Surgical Motor Pro 2 | 2026-01-12 |
| 04589551384082 - Straumann SGL80M | 2026-01-12 |
| 04589551384082 - Straumann SGL80M | 2026-01-12 |
| 04589551355495 - NSK Sterile Burs/Drills | 2025-12-22 |
| 04589551355501 - NSK Sterile Burs/Drills | 2025-12-22 |
| 04589551393367 - PANA SPRAY Plus | 2025-10-02 |
| 04560264576940 - SG20M | 2025-09-05 |
| 04560264576957 - X-SG20ML | 2025-09-05 |
| 04589551381500 - NLZ | 2025-09-03 |