Nobel Biocare® 34582
GUDID 07332747190038
Twist Step Drill 4.2/4.6 7-15mm
Nobel Biocare AB
Fluted surgical drill bit, single-use| Primary Device ID | 07332747190038 |
| NIH Device Record Key | 41532b08-e496-4d21-90b9-9adf8b72e71e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Nobel Biocare® |
| Version Model Number | 34582 |
| Catalog Number | 34582 |
| 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 | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 Millimeter |
| Length | 15 Millimeter |
| Outer Diameter | 4.6 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 |
| 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 | 07332747190038 [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 [Nobel Biocare®]
| 07332747092653 | Guided Tissue Punch for WP/6.0-sleeve (5.5) |
| 07332747092646 | Guided Tissue Punch for NP-sleeve (3.75) |
| 07332747092509 | Guided Twist Step Drill Ø4.2/4.6 (10+) 7-18mm |
| 07332747091076 | Guided Twist Step Drill 4.2/5.0 (10+) 7-18mm |
| 07332747091069 | Guided Twist Step Drill 4.2/5.0 (10+) 7-13mm |
| 07332747079074 | Guided Pilot Twist Drill 1.5x(10+)10-15mm |
| 07332747073768 | Pilot Drill 3.0/4.2mm |
| 07332747073751 | Pilot Drill 2.0/3.0mm |
| 07332747073744 | Pilot Drill 2.0/2.8mm |
| 07332747070392 | Guided Tissue Punch for WP/6.0-sleeve (5.0mm implants) |
| 07332747070347 | Guided Tissue Punch for WP/6.0-sleeve (6.0mm implants) |
| 07332747070330 | Guided Tissue Punch for NP-sleeve |
| 07332747070323 | Guided Tissue Punch for RP-sleeve |
| 07332747070316 | Guided Start Drill |
| 07332747069808 | Guided ScrewTap Tapered NP |
| 07332747034622 | Guided Twist Drill Tapered 2x(10+)8-16mm |
| 07332747015782 | Guided Twist Step Drill Ø4.2/4.6 (10+) 7-13mm |
| 07332747015775 | Guided Twist Step Drill Ø3.8/4.2 (10+) 7-18mm |
| 07332747015768 | Guided Twist Step Drill Ø3.8/4.2 (10+) 7-13mm |
| 07332747015751 | Guided Twist Step Drill Ø3.2/3.6 (10+) 7-18mm |
| 07332747015744 | Guided Twist Step Drill Ø3.2/3.6 (10+) 7-13mm |
| 07332747015737 | Guided Twist Step Drill Ø2.8/3.2 (10+) 7-18mm |
| 07332747015720 | Guided Twist Step Drill Ø2.8/3.2 (10+) 7-13mm |
| 07332747015713 | Guided Twist Step Drill Ø2.4/2.8 (10+) 7-18mm |
| 07332747015706 | Guided Twist Step Drill Ø2.4/2.8 (10+) 7-13mm |
| 07332747015492 | Guided Drill Tapered WP 5x(+)11.5mm |
| 07332747015485 | Guided Drill Tapered RP 4.3x(+)11.5mm |
| 07332747015478 | Guided Drill Tapered NP 3.5x(+)11.5mm |
| 07332747015461 | Guided Drill Tapered 6.0 6x(+)11.5mm |
| 07332747008890 | Guided Screw Tap WP Ø5 7-13mm |
| 07332747008883 | Guided Screw Tap Tapered WP |
| 07332747008876 | Guided Screw Tap Tapered RP |
| 07332747008852 | Guided Screw Tap Tapered 6.0 |
| 07332747008845 | Guided Screw Tap RP Ø4 7-13mm |
| 07332747008838 | Guided Screw Tap RP Ø3.75 7-13mm |
| 07332747008821 | Guided Screw Tap NP 10-13mm |
| 07332747006841 | Guided Twist Drill Ø1.5mmx20mm |
| 07332747006834 | Guided Twist Drill 5x(10+)7-13mm |
| 07332747006827 | Guided Twist Drill 4.2x(10+)7-18mm |
| 07332747006810 | Guided Twist Drill 4.2x(10+)7-13mm |
| 07332747006803 | Guided Twist Drill 3x(10+)7-18mm |
| 07332747006797 | Guided Twist Drill 3x(10+)7-13mm |
| 07332747006780 | Guided Twist Drill 3.8x(10+)7-18mm |
| 07332747006773 | Guided Twist Drill 3.8x(10+)7-13mm |
| 07332747006766 | Guided Twist Drill 3.4x(10+)7-18mm |
| 07332747006759 | Guided Twist Drill 3.4x(10+)7-13mm |
| 07332747006742 | Guided Twist Drill 3.2x(10+)7-18mm |
| 07332747006735 | Guided Twist Drill 3.2x(10+)7-13mm |
| 07332747006728 | Guided Twist Drill 2x(10+)7-18mm |
| 07332747006711 | Guided Twist Drill 2x(10+)7-13mm |
Trademark Results [Nobel Biocare]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NOBEL BIOCARE 75010184 2515631 Live/Registered |
NOBEL BIOCARE SERVICES AG 1995-10-18 |
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