NeoMTA Plus
GUDID 08575700061252
Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This cement is supplied as a powder and gel for mixing prior to use. Cement is radiopaque.
Avalon Biomed Inc.
Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material Endodontic filling/sealing material| Primary Device ID | 08575700061252 |
| NIH Device Record Key | eed9b6f2-2c00-4107-88dc-e7131bbb1998 |
| Commercial Distribution Discontinuation | 2017-12-31 |
| Commercial Distribution Status | Not in Commercial Distribution |
| Brand Name | NeoMTA Plus |
| Version Model Number | MN250 |
| Company DUNS | 969855647 |
| Company Name | Avalon Biomed Inc. |
| 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 | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Device Dimensions
| Weight | 2.5 Gram |
| Weight | 2.5 Gram |
| Weight | 2.5 Gram |
| Weight | 2.5 Gram |
| Weight | 2.5 Gram |
| Weight | 2.5 Gram |
| Weight | 2.5 Gram |
| Weight | 2.5 Gram |
| Weight | 2.5 Gram |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
| Special Storage Condition, Specify | Between 0 and 0 *Moisture will reduce the shelf life of the powder |
| Special Storage Condition, Specify | Between 0 and 0 *Keep bottle tightly closed |
| Special Storage Condition, Specify | Between 0 and 0 *Do not refrigerate |
| Special Storage Condition, Specify | Between 0 and 0 *Store at room temperature |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 08575700061252 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K140955
FDA Product Code
| KIF | Resin, Root Canal Filling |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 4 |
| Public Version Date | 2021-08-19 |
| Device Publish Date | 2017-12-19 |
On-Brand Devices [NeoMTA Plus]
| 00857570006167 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 00857570006150 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 00857570006143 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 00857570006112 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 00857570006105 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 00857570006099 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 00857570006082 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 00857570006075 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 00857570006068 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
| 08575700061252 | Tricalcium silicate-based cement for contact with vital pulp and periradicular tissues. This ce |
Trademark Results [NeoMTA Plus]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NEOMTA PLUS 86517534 4917682 Live/Registered |
NUSMILE, LTD. 2015-01-28 |
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