Ultra-Bond® 031982210
GUDID D8130319822101
TRY-IN B0 SY 4pc KIT
DEN-MAT HOLDINGS, LLC
Dental composite resin| Primary Device ID | D8130319822101 |
| NIH Device Record Key | 689e94ac-acc3-4070-8619-64b66b9039f1 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Ultra-Bond® |
| Version Model Number | 031982210 |
| Catalog Number | 031982210 |
| Company DUNS | 809857704 |
| Company Name | DEN-MAT HOLDINGS, LLC |
| Device Count | 4 |
| 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 | false |
| 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 |
Operating and Storage Conditions
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
| Handling Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Storage Environment Temperature | Between 33 Degrees Fahrenheit and 75 Degrees Fahrenheit |
| Special Storage Condition, Specify | Between 0 and 0 *Refrigerate Ultra-Bond Plus resin cement |
| Special Storage Condition, Specify | Between 0 and 0 *Bring to room temperature prior to use |
| Special Storage Condition, Specify | Between 0 and 0 *Do not freeze |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D8130319822100 [Unit of Use] |
| HIBCC | D8130319822101 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K881918
FDA Product Code
| EMA | Cement, Dental |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | false |
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 3 |
| Public Version Date | 2018-07-06 |
| Device Publish Date | 2016-09-24 |
On-Brand Devices [Ultra-Bond®]
| D813325999500 | U-BOND PLUS CUSTOM KIT |
| D8130325999500 | U-BOND PLUS CUSTOM KIT |
| D8130325997500 | U-BOND PLUS MULTI SH 6g KIT R1 |
| D8130325993900 | UB PLUS A2 DC 6g RFL KIT |
| D8130325993800 | UB PLUS SUP WHT DC RFL KIT R:1 |
| D8130325993700 | UB PLUS NEU DC 6g RFL KIT R:1 |
| D8130325993500 | UB PLUS B0 DC 6g RFL KIT |
| D8130325993300 | UB PLUS B1 DC 6g RFL KIT |
| D8130325993100 | UB PLUS A1 DC 6g RFL KIT R:1 |
| D8130325991100 | U-BOND PLUS M/S INTRO KIT |
| D8130324921100 | BLOCK OUT UBP M/S INTRO KIT |
| D8130324915500 | BLOCK OUT UBP M/S BTO KIT |
| D8130324915100 | BLOCK OUT UBP M/S BONDING KIT |
| D8130324914100 | BLOCK OUT UBP SUP WHT KT |
| D8130324913100 | BLOCK OUT UBP B0 KIT |
| D8130324912100 | BLOCK OUT UBP B1 KIT |
| D8130324911100 | BLOCK OUT UBP A1 KIT |
| D8130319828101 | TRY-IN SUP WHT SY 4pc KIT |
| D8130319827101 | TRY-IN NEUTRAL SY 4pc KIT |
| D8130319825101 | TRY-IN A1 SY 4pc KIT |
| D8130319823101 | TRY-IN B1 SY 4pc KIT |
| D8130319822101 | TRY-IN B0 SY 4pc KIT |
| D8130313435500 | TRY-IN MULTI-SHADE PST KIT |
Trademark Results [Ultra-Bond]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRA-BOND 87004513 5049887 Live/Registered |
Great American Insurance Company 2016-04-18 |
 ULTRA-BOND 85687480 4305162 Live/Registered |
P.F.I., Inc. 2012-07-26 |
 ULTRA-BOND 75376128 2574812 Live/Registered |
SWIMC LLC 1997-10-20 |
 ULTRA-BOND 74325454 1795026 Live/Registered |
GREIF INTERNATIONAL HOLDING B.V. 1992-10-26 |
 ULTRA-BOND 73416681 1310732 Live/Registered |
Den-Mat, Inc. 1983-03-10 |
 ULTRA-BOND 73105855 1079623 Live/Registered |
RFR CORP. 1976-11-08 |
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