Ultra-Bond® 031982210
GUDID D8130319822101
TRY-IN B0 SY 4pc KIT
DEN-MAT HOLDINGS, LLC
Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin 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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