Brånemark System® 28924
GUDID 07332747159578
Brånemark System Mk III TiU RP 4.0x18mm
Nobel Biocare AB
Screw endosteal dental implant, two-piece| Primary Device ID | 07332747159578 |
| NIH Device Record Key | 812e46ff-5ce1-4995-806a-79141a28a741 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Brånemark System® |
| Version Model Number | 28924 |
| Catalog Number | 28924 |
| 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 | true |
| 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 | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 Millimeter |
| Outer Diameter | 4 Millimeter |
| Length | 18 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 |
| Special Storage Condition, Specify | Between 0 and 0 *Keep away from sunlight. Keep dry |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07332747159578 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K945398
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 | 2019-07-17 |
| Device Publish Date | 2019-07-09 |
On-Brand Devices [Brånemark System®]
| 07332747112467 | Brånemark System® Zygoma Angled Multi-unit Abutment Screw |
| 07332747073805 | Brånemark System Counterbore Mk III RP, long shaft |
| 07332747073782 | Brånemark System Counterbore Mk III RP |
| 07332747073775 | Brånemark System Counterbore Mk III NP |
| 07332747029345 | Brånemark System® Twist drill Ø 3.15 mm 7-15 mm |
| 07332747029260 | Brånemark System® Counterbore short |
| 07332747024708 | Twist Drill Brånemark System® RP 1.6 mm |
| 07332747024692 | Twist Drill Brånemark System® NP 1.3 mm |
| 07332747023053 | Screw Tap Repair Brånemark System® WP |
| 07332747023046 | Screw Tap Repair Brånemark System® RP |
| 07332747023039 | Screw Tap Repair Brånemark System® NP |
| 07332747013528 | Brånemark System® Zygoma TiU 52.5mm |
| 07332747013511 | Brånemark System® Zygoma TiU 50mm |
| 07332747013504 | Brånemark System® Zygoma TiU 47.5mm |
| 07332747013498 | Brånemark System® Zygoma TiU 45mm |
| 07332747013481 | Brånemark System® Zygoma TiU 42.5mm |
| 07332747013474 | Brånemark System® Zygoma TiU 40mm |
| 07332747013467 | Brånemark System® Zygoma TiU 35mm |
| 07332747013450 | Brånemark System® Zygoma TiU 30mm |
| 07332747013436 | Brånemark System® Zygoma Round Bur |
| 07332747013344 | Brånemark System Mk IV TiU WP 5.0x8.5mm |
| 07332747013337 | Brånemark System Mk IV TiU WP 5.0x7mm |
| 07332747013320 | Brånemark System Mk IV TiU WP 5.0x15mm |
| 07332747013313 | Brånemark System Mk IV TiU WP 5.0x13mm |
| 07332747013306 | Brånemark System Mk IV TiU WP 5.0x11.5mm |
| 07332747013290 | Brånemark System Mk IV TiU WP 5.0x10mm |
| 07332747013283 | Brånemark System Mk IV TiU RP 4.0x8.5mm |
| 07332747013276 | Brånemark System Mk IV TiU RP 4.0x7mm |
| 07332747013269 | Brånemark System Mk IV TiU RP 4.0x18mm |
| 07332747013252 | Brånemark System Mk IV TiU RP 4.0x15mm |
| 07332747013245 | Brånemark System Mk IV TiU RP 4.0x13mm |
| 07332747013238 | Brånemark System Mk IV TiU RP 4.0x11.5mm |
| 07332747013221 | Brånemark System Mk IV TiU RP 4.0x10mm |
| 07332747013078 | Bmk Syst Zygoma Twist Drill 3.5 mm short |
| 07332747013061 | Bmk Syst Zygoma Twist Drill 3.5 mm |
| 07332747013054 | Bmk Syst Zygoma Twist Drill 2.9 mm short |
| 07332747013047 | Bmk Syst Zygoma Pilot Drill 3.5 mm short |
| 07332747013030 | Bmk Syst Zygoma Pilot Drill 3.5 mm |
| 07332747009682 | Brånemark System® Second Stage Surg Kit. The kit includes manual Bone Mills and Cover Screw Mi |
| 07332747006414 | Bmk Syst Zygoma Twist Drill 2.9 mm |
| 07332747005264 | Guided Start Drill/Counterbore Brånemark System® WP Ø6 |
| 07332747005257 | Guided Start Drill/Counterbore Brånemark System® WP Ø5 |
| 07332747005240 | Guided Start Drill/Counterb Brånemark System® RP |
| 07332747005233 | Guided Start Drill/Counterbore Brånemark System® NP |
| 07332747005189 | Brånemark System® Counterbore WP |
| 07332747005172 | Brånemark System® Counterbore RP |
| 07332747005165 | Brånemark System® Counterbore NP |
| 07332747005028 | Bone Mill with Guide Brånemark System® WP Ø6.5 |
| 07332747005011 | Bone Mill with Guide Brånemark System® RP Ø5.1 |
| 07332747005004 | Bone Mill with Guide Brånemark System® NP Ø4.5 |
Trademark Results [Brånemark System]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRANEMARK SYSTEM 74486952 1917780 Dead/Cancelled |
NOBELPHARMA AB 1994-02-04 |
 BRANEMARK SYSTEM 73671730 1587384 Live/Registered |
NOBELPHARMA AB 1987-07-13 |
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