NobelSpeedy® 37611
GUDID 07332747161021
NobelSpeedy® Groovy RP 4.0x20mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece| Primary Device ID | 07332747161021 |
| NIH Device Record Key | 633232c1-ee63-40b7-87ed-51d1bb82e5ad |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelSpeedy® |
| Version Model Number | 37611 |
| Catalog Number | 37611 |
| Company DUNS | 353939929 |
| Company Name | Nobel Biocare AB |
| 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 | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | true |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
Device Dimensions
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 20 Millimeter |
| Outer Diameter | 4 Millimeter |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight.Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747161021 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K160119
FDA Product Code
| DZE | IMPLANT, ENDOSSEOUS, ROOT-FORM |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2019-07-24 |
| Device Publish Date | 2019-07-16 |
On-Brand Devices [NobelSpeedy®]
| 07332747087062 | NobelSpeedy® Groovy RP 5.0x18mm |
| 07332747087055 | NobelSpeedy® Groovy RP 5.0x15mm |
| 07332747087048 | NobelSpeedy® Groovy RP 5.0x13mm |
| 07332747087031 | NobelSpeedy® Groovy RP 5.0x11.5mm |
| 07332747087024 | NobelSpeedy® Groovy RP 5.0x10mm |
| 07332747087017 | NobelSpeedy® Groovy RP 5.0x8.5mm |
| 07332747087000 | NobelSpeedy® Groovy RP 5.0x7mm |
| 07332747086287 | NobelSpeedy® Shorty NP Ø3.3mm |
| 07332747086270 | NobelSpeedy® Groovy NP 3.3x8.5mm |
| 07332747086263 | NobelSpeedy® Groovy RP 4.0x20mm |
| 07332747086256 | NobelSpeedy® Groovy RP 4.0x22mm |
| 07332747086249 | NobelSpeedy® Groovy RP 4.0x25mm |
| 07332747008814 | Guided Screw Tap 6.0/WP Ø6 7-13mm |
| 07332747001785 | NOBELSPEEDY Replace WP 5x18mm |
| 07332747001778 | NOBELSPEEDY Replace WP 5x15mm |
| 07332747001761 | NOBELSPEEDY Replace WP 5x13mm |
| 07332747001754 | NOBELSPEEDY Replace WP 5x11.5mm |
| 07332747001747 | NOBELSPEEDY Replace WP 5x10mm |
| 07332747001730 | NOBELSPEEDY Replace RP 4x18mm |
| 07332747001723 | NOBELSPEEDY Replace RP 4x15mm |
| 07332747001716 | NOBELSPEEDY Replace RP 4x13mm |
| 07332747001709 | NOBELSPEEDY Replace RP 4x11.5mm |
| 07332747001693 | NOBELSPEEDY Replace RP 4x10mm |
| 07332747001686 | NOBELSPEEDY Replace NP 3.5x15mm |
| 07332747001679 | NOBELSPEEDY Replace NP 3.5x13mm |
| 07332747001662 | NOBELSPEEDY Replace NP 3.5x11.5mm |
| 07332747001655 | NOBELSPEEDY Replace NP 3.5x10mm |
| 07332747001648 | NOBELSPEEDY Replace 6.0 6x18mm |
| 07332747001631 | NOBELSPEEDY Replace 6.0 6x15mm |
| 07332747001624 | NOBELSPEEDY Replace 6.0 6x13mm |
| 07332747001617 | NOBELSPEEDY Replace 6.0 6x11.5mm |
| 07332747001600 | NOBELSPEEDY Replace 6.0 6x10mm |
| 07332747001594 | NobelSpeedy® Groovy WP 5.0x18mm |
| 07332747001587 | NobelSpeedy® Groovy WP 5.0x15mm |
| 07332747001570 | NobelSpeedy® Groovy WP 5.0x13mm |
| 07332747001563 | NobelSpeedy® Groovy WP 5.0x11.5mm |
| 07332747001556 | NobelSpeedy® Groovy WP 5.0x10mm |
| 07332747001549 | NobelSpeedy® Groovy WP 5.0x8.5mm |
| 07332747001532 | NobelSpeedy® Groovy RP 4.0x18mm |
| 07332747001525 | NobelSpeedy® Groovy RP 4.0x15mm |
| 07332747001518 | NobelSpeedy® Groovy RP 4.0x13mm |
| 07332747001501 | NobelSpeedy® Groovy RP 4.0x11.5mm |
| 07332747001495 | NobelSpeedy® Groovy RP 4.0x10mm |
| 07332747001488 | NobelSpeedy® Groovy RP 4.0x8.5mm |
| 07332747001471 | NobelSpeedy® Groovy NP 3.3x15mm |
| 07332747001464 | NobelSpeedy® Groovy NP 3.3x13mm |
| 07332747001457 | NobelSpeedy® Groovy NP 3.3x11.5mm |
| 07332747001440 | NobelSpeedy® Groovy NP 3.3x10mm |
| 07332747001433 | NobelSpeedy® Groovy WP 6.0x18mm |
| 07332747001426 | NobelSpeedy® Groovy WP 6.0x15mm |
Trademark Results [NobelSpeedy]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELSPEEDY 78723723 3665103 Live/Registered |
Nobel Biocare Services AG 2005-09-29 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.