NobelReplace® 37089
GUDID 07332747202656
Drill Tapered 6.0 6x8 mm Single-Patient Use
Nobel Biocare AB
Fixture/appliance dental drill bit, single-use| Primary Device ID | 07332747202656 |
| NIH Device Record Key | e78122da-4ac7-4e20-911b-4e2da7b9da64 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | NobelReplace® |
| Version Model Number | 37089 |
| Catalog Number | 37089 |
| 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
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 Millimeter |
| Length | 8 Millimeter |
| Outer Diameter | 6 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 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747202656 [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 | 2024-06-05 |
| Device Publish Date | 2024-05-28 |
On-Brand Devices [NobelReplace®]
| 07332747073645 | NobelReplace® Conical Connection PMC NP 3.5x8mm |
| 07332747073638 | NobelReplace® Conical Connection PMC NP 3.5x10mm |
| 07332747073621 | NobelReplace® Conical Connection PMC NP 3.5x11.5mm |
| 07332747073614 | NobelReplace® Conical Connection PMC NP 3.5x13mm |
| 07332747073607 | NobelReplace® Conical Connection PMC NP 3.5x16mm |
| 07332747073591 | NobelReplace® Conical Connection PMC RP 4.3x8mm |
| 07332747073584 | NobelReplace® Conical Connection PMC RP 4.3x10mm |
| 07332747073577 | NobelReplace® Conical Connection PMC RP 4.3x11.5mm |
| 07332747073560 | NobelReplace® Conical Connection PMC RP 4.3x13mm |
| 07332747073553 | NobelReplace® Conical Connection PMC RP 4.3x16mm |
| 07332747073546 | NobelReplace® Conical Connection PMC RP 5.0x8mm |
| 07332747073539 | NobelReplace® Conical Connection PMC RP 5.0x10mm |
| 07332747073522 | NobelReplace® Conical Connection PMC RP 5.0x11.5mm |
| 07332747073515 | NobelReplace® Conical Connection PMC RP 5.0x13mm |
| 07332747073508 | NobelReplace® Conical Connection PMC RP 5.0x16mm |
| 07332747070385 | Guided Counterbore NobelReplace® 6.0 |
| 07332747070378 | Guided Counterbore NobelReplace® 5.0 |
| 07332747070361 | Guided Counterbore NobelReplace® 4.3 |
| 07332747070354 | Guided Counterbore NobelReplace® 3.5 |
| 07332747070293 | NobelReplace® Tapered Guided Surgery Basic Kit |
| 07332747037326 | NobelReplace™ Tapered Surgery Kit - The kit includes instruments to perform implant surgery fo |
| 07332747035773 | NobelReplace® Conical Connection NP 3.5x8mm |
| 07332747035766 | NobelReplace® Conical Connection NP 3.5x10mm |
| 07332747035759 | NobelReplace® Conical Connection NP 3.5x11.5mm |
| 07332747035742 | NobelReplace® Conical Connection NP 3.5x13mm |
| 07332747035735 | NobelReplace® Conical Connection NP 3.5x16mm |
| 07332747035728 | NobelReplace® Conical Connection RP 4.3x8mm |
| 07332747035711 | NobelReplace® Conical Connection RP 4.3x10mm |
| 07332747035704 | NobelReplace® Conical Connection RP 4.3x11.5mm |
| 07332747035698 | NobelReplace® Conical Connection RP 4.3x13mm |
| 07332747035681 | NobelReplace® Conical Connection RP 4.3x16mm |
| 07332747035674 | NobelReplace® Conical Connection RP 5.0x8mm |
| 07332747035667 | NobelReplace® Conical Connection RP 5.0x10mm |
| 07332747035650 | NobelReplace® Conical Connection RP 5.0x11.5mm |
| 07332747035643 | NobelReplace® Conical Connection RP 5.0x13mm |
| 07332747035636 | NobelReplace® Conical Connection RP 5.0x16mm |
| 07332747034141 | NobelReplace PS NP 4.3x8mm |
| 07332747034134 | NobelReplace PS NP 4.3x10mm |
| 07332747034127 | NobelReplace PS NP 4.3x11.5mm |
| 07332747034110 | NobelReplace PS NP 4.3x13mm |
| 07332747034103 | NobelReplace PS NP 4.3x16mm |
| 07332747034097 | NobelReplace PS RP 5.0x8mm |
| 07332747034080 | NobelReplace PS RP 5.0x10mm |
| 07332747034073 | NobelReplace PS RP 5.0x11.5mm |
| 07332747034066 | NobelReplace PS RP 5.0x13mm |
| 07332747034059 | NobelReplace PS RP 5.0x16mm |
| 07332747034042 | NobelReplace PS WP 6.0x8mm |
| 07332747034035 | NobelReplace PS WP 6.0x10mm |
| 07332747034028 | NobelReplace PS WP 6.0x11.5mm |
| 07332747034011 | NobelReplace PS WP 6.0x13mm |
Trademark Results [NobelReplace]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBELREPLACE 79028282 not registered Dead/Abandoned |
Nobel Biocare AB 2006-02-14 |
NOBELREPLACE 79028282 not registered Dead/Abandoned |
Nobel Biocure Services AG 2006-02-14 |
 NOBELREPLACE 79018918 3211602 Live/Registered |
Nobel Biocure Services AG 2005-07-13 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.