NobelParallel™ 38002
GUDID 07332747191349
NobelParallel™ CC Cortical Drill 5.0mm
Nobel Biocare AB
Fixture/appliance dental drill bit, single-use| Primary Device ID | 07332747191349 |
| NIH Device Record Key | 16b57f55-b2ee-46d1-8e44-b51dd3aaf2b3 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelParallel™ |
| Version Model Number | 38002 |
| Catalog Number | 38002 |
| 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 | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 Millimeter |
| Outer Diameter | 5 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747191349 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K990846
FDA Product Code
| DZI | DRILL, BONE, POWERED |
| NDP | Accessories, implant, dental, endosseous |
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 | 2024-06-06 |
| Device Publish Date | 2024-05-29 |
On-Brand Devices [NobelParallel™]
| 07332747124491 | Screw Tap NobelParallel™ Trefoil™ 5.5 x 11.5-13mm |
| 07332747124484 | Screw Tap NobelParallel™ Trefoil™ 5.0 x 11.5-13mm |
| 07332747124477 | Screw Tap NobelParallel™ Trefoil™ 4.3 x 11.5-13mm |
| 07332747124255 | NobelParallel™ CC Tissue Collar RP 5.5 x 13+4.5mm |
| 07332747124248 | NobelParallel™ CC Tissue Collar RP 5.5 x 11.5+4.5mm |
| 07332747124231 | NobelParallel™ CC Tissue Collar RP 5.0 x 13+4.5mm |
| 07332747124224 | NobelParallel™ CC Tissue Collar RP 5.0 x 11.5+4.5mm |
| 07332747124217 | NobelParallel™ CC Tissue Collar RP 4.3 x 13+4.5mm |
| 07332747124200 | NobelParallel™ CC Tissue Collar RP 4.3 x 11.5+4.5mm |
| 07332747092776 | NobelParallel™ Conical Connection Guided Surgery Kit |
| 07332747092691 | Guided Counterbore NobelParallel™ CC 5.5 |
| 07332747092684 | Guided Counterbore NobelParallel™ CC 5.0 |
| 07332747092677 | Guided Counterbore NobelParallel™ CC 4.3 |
| 07332747092660 | Guided Counterbore NobelParallel™ CC 3.75 |
| 07332747092639 | Guided Screw Tap NobelParallel™ CC 5.5 11.5-15mm |
| 07332747092622 | Guided Screw Tap NobelParallel™ CC 5.5 11.5-13mm |
| 07332747092615 | Guided Screw Tap NobelParallel™ CC 5.5 7-10mm |
| 07332747092608 | Guided Screw Tap NobelParallel™ CC 5.0 15-18mm |
| 07332747092592 | Guided Screw Tap NobelParallel™ CC 5.0 11.5-13mm |
| 07332747092585 | Guided Screw Tap NobelParallel™ CC 5.0 7-10mm |
| 07332747092578 | Guided Screw Tap NobelParallel™ CC 4.3 15-18mm |
| 07332747092561 | Guided Screw Tap NobelParallel™ CC 4.3 11.5-13mm |
| 07332747092554 | Guided Screw Tap NobelParallel™ CC 4.3 7-10mm |
| 07332747092547 | Guided Screw Tap NobelParallel™ CC 3.75 15-18mm |
| 07332747092530 | Guided Screw Tap NobelParallel™ CC 3.75 11.5-13mm |
| 07332747092523 | Guided Screw Tap NobelParallel™ CC 3.75 7-10mm |
| 07332747091830 | NobelParallel™ Conical Connection Surgery Kit. The kit includes instruments to perform implan |
| 07332747091823 | NobelParallel™ CC Cortical Drill 5.5mm |
| 07332747091816 | NobelParallel™ CC Cortical Drill 5.0mm |
| 07332747091809 | NobelParallel™ CC Cortical Drill 4.3mm |
| 07332747091793 | NobelParallel™ CC Cortical Drill 3.75mm |
| 07332747091762 | Screw Tap NobelParallel™ CC 5.5 7-15mm |
| 07332747091755 | Screw Tap NobelParallel™ CC 5.5 7-10mm |
| 07332747091748 | Screw Tap NobelParallel™ CC 5.0 7-18mm |
| 07332747091731 | NobelParallel CC WP 5.5x7mm |
| 07332747091724 | NobelParallel CC RP 5.0x18mm |
| 07332747091717 | NobelParallel CC RP 5.0x15mm |
| 07332747091700 | NobelParallel CC RP 5.0x13mm |
| 07332747091649 | Screw Tap NobelParallel™ CC 5.0 7-13mm |
| 07332747091632 | Screw Tap NobelParallel™ CC 4.3 7-18mm |
| 07332747091625 | Screw Tap NobelParallel™ CC 4.3 7-13mm |
| 07332747091618 | Screw Tap NobelParallel™ CC 3.75 7-18mm |
| 07332747091601 | Screw Tap NobelParallel™ CC 3.75 7-13mm |
| 07332747091595 | NobelParallel CC RP 5.0x11.5mm |
| 07332747091588 | NobelParallel CC RP 5.0x10mm |
| 07332747091571 | NobelParallel CC RP 5.0x8.5mm |
| 07332747091564 | NobelParallel CC RP 5.0x7mm |
| 07332747091557 | NobelParallel CC RP 4.3x18mm |
| 07332747091540 | NobelParallel CC RP 4.3x15mm |
| 07332747091533 | NobelParallel CC RP 4.3x13mm |
Trademark Results [NobelParallel]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELPARALLEL 79359418 not registered Live/Pending |
Nobel Biocare Services AG 2022-09-15 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.