BELLATEK®
GUDID 00844868038047
BELLATEK® ZIRCONIA ABUTMENT TSV 4.5MM
BIOMET 3I, LLC
Dental implant suprastructure, permanent, preformed| Primary Device ID | 00844868038047 |
| NIH Device Record Key | 4251d1ec-ba7d-496b-a8fb-bc533fe52042 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | BELLATEK® |
| Version Model Number | TSVIOSEDAZR4 |
| Company DUNS | 186127825 |
| Company Name | BIOMET 3I, LLC |
| 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 | false |
| Expiration Date | false |
| 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
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com | |
| Phone | +1(800)342-5454 |
| 3iPBG-CS@biomet.com |
Device Dimensions
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00844868038047 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K080164
FDA Product Code
| NHA | ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
[00844868038047]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2019-11-08 |
| Device Publish Date | 2017-02-07 |
On-Brand Devices [BELLATEK®]
| 00844868038092 | BELLATEK® ABUTMENT TSV 4.5MM |
| 00844868038085 | BELLATEK® ZIRCONIA ABUTMENT TSV 4.5MM |
| 00844868038078 | BELLATEK® ZIRCONIA ABUTMENT TSV 3.5MM |
| 00844868038061 | BELLATEK® ZIRCONIA ABUTMENT TSV 4.5MM |
| 00844868038054 | BELLATEK® ZIRCONIA ABUTMENT TSV 3.5MM |
| 00844868038047 | BELLATEK® ZIRCONIA ABUTMENT TSV 4.5MM |
| 00844868038030 | BELLATEK® ZIRCONIA ABUTMENT TSV 3.5MM |
| 00844868038023 | BELLATEK® ZIRCONIA ABUTMENT TSV 4.5MM |
| 00844868038016 | BELLATEK® ZIRCONIA ABUTMENT TSV 3.5MM |
| 00844868038009 | BELLATEK® ABUTMENT TSV 5.7MM |
| 00844868037996 | BELLATEK® ABUTMENT TSV 4.5MM |
| 00844868037989 | BELLATEK® ABUTMENT TSV 3.5MM |
| 00844868037972 | BELLATEK® ABUTMENT TSV 5.7MM |
| 00844868037965 | BELLATEK® ABUTMENT TSV 3.5MM |
| 00844868037958 | BELLATEK® ABUTMENT TSV 5.7MM |
| 00844868037941 | BELLATEK® ABUTMENT TSV 4.5MM |
| 00844868037934 | BELLATEK® ABUTMENT TSV 3.5MM |
| 00844868037927 | BELLATEK® ABUTMENT TSV 5.7MM |
| 00844868037910 | BELLATEK® ABUTMENT TSV 4.5MM |
| 00844868037903 | BELLATEK® ABUTMENT TSV 3.5MM |
| 00844868033585 | BELLATEK® TITANIUM ABUTMENT 6.0MM |
| 00844868033578 | BELLATEK® TITANIUM ABUTMENT 5.0MM |
| 00844868033561 | BELLATEK® TITANIUM ABUTMENT 4.1MM |
| 00844868033554 | BELLATEK® TITANIUM ABUTMENT 3.4MM |
| 00844868033547 | BELLATEK® TIN ABUTMENT 6.0MM |
| 00844868033530 | BELLATEK® TIN ABUTMENT 5.0MM |
| 00844868033523 | BELLATEK® TIN ABUTMENT 4.1MM |
| 00844868033516 | BELLATEK® TIN ABUTMENT 3.4MM |
| 00844868031727 | BELLATEK® TITANIUM ABUTMENT 6.0MM |
| 00844868031710 | BELLATEK® TITANIUM ABUTMENT 5.0MM |
| 00844868031703 | BELLATEK® TITANIUM ABUTMENT 4.1MM |
| 00844868031697 | BELLATEK® TITANIUM ABUTMENT 3.4MM |
| 00844868031680 | BELLATEK® TIN ABUTMENT 6.0MM |
| 00844868031673 | BELLATEK® TIN ABUTMENT 5.0MM |
| 00844868031666 | BELLATEK® TIN ABUTMENT 4.1MM |
| 00844868031659 | BELLATEK® TIN ABUTMENT 3.4MM |
| 00844868031642 | BELLATEK® TITANIUM ABUTMENT 6.0MM |
| 00844868031635 | BELLATEK® TITANIUM ABUTMENT 5.0MM |
| 00844868031628 | BELLATEK® TITANIUM ABUTMENT 4.1MM |
| 00844868031611 | BELLATEK® TITANIUM ABUTMENT 3.4MM |
| 00844868031604 | BELLATEK® TIN ABUTMENT 6.0MM |
| 00844868031598 | BELLATEK® TIN ABUTMENT 5.0MM |
| 00844868031581 | BELLATEK® TIN ABUTMENT 4.1MM |
| 00844868031574 | BELLATEK® TIN ABUTMENT 3.4MM |
| 00844868031123 | BELLATEK® TITANIUM ABUTMENT 6.0MM |
| 00844868031116 | BELLATEK® TITANIUM ABUTMENT 5.0MM |
| 00844868031109 | BELLATEK® TITANIUM ABUTMENT 4.1MM |
| 00844868031093 | BELLATEK® TITANIUM ABUTMENT 3.4MM |
| 00844868031086 | BELLATEK® TIN ABUTMENT 6.0MM |
| 00844868031079 | BELLATEK® TIN ABUTMENT 5.0MM |
Trademark Results [BELLATEK]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BELLATEK 85295982 4226665 Live/Registered |
Biomet 3i, LLC 2011-04-15 |
 BELLATEK 85223430 4191440 Live/Registered |
Biomet 3i, LLC 2011-01-21 |
 BELLATEK 77124343 3561738 Dead/Cancelled |
Lead Data International, Inc. 2007-03-07 |
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