Dam Frame
- Primary DI
- D701RDF2
- Brand
- Dam Frame
- Company
- PULPDENT CORPORATION
- Model
- RDF
- Device description
- Radiolucent Rubber Dam Frame
- Published
- 2021-09-21
- Public version status
- New
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- false
- OTC
- false
- Sterile
- false
- Single use
- false
Product Codes
| Code | Name |
|---|
| EJE | Frame, Rubber Dam |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| EJE | Frame, Rubber Dam | Dental | 1 |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| D701RDF2 | Primary | HIBCC | 0 | |
GMDN Terms
| Term | Definition |
|---|
| Rubber dam frame | A flexible border that holds a rubber dam in a stretched state to improve access to the field of operation. It is typically made of a thick stainless steel U-shaped rod that has small hook-like retainers attached at intervals along its length. This is a reusable device. |
Sterilization Methods
| Method |
|---|
| High-level Disinfectant |
Regulatory Flags
- DUNS number
- 001006089
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- true
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- false
- Manufacturing date on label
- false
- Expiration date on label
- false
- Donation ID number
- false
- Contains natural rubber latex
- false
- No natural rubber latex
- false
- Sterilization required before use
- true
Other Devices From This Company
Other Devices Sharing Product Codes
| Primary DI | Brand | Company | Product code | Published |
|---|
| 00813677023339 | PDT, Inc. | PDT, INC. | EJE | 2024-06-27 |
| D2483553190 | Plast Frame | HAGER WORLDWIDE, INC. | EJE | 2024-04-16 |
| 08800075603463 | OSUNG MND | OSUNG MND Co., Ltd. | EJE | 2024-02-23 |
| 08800075603470 | OSUNG MND | OSUNG MND Co., Ltd. | EJE | 2024-02-23 |
| 07506338321761 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2023-11-17 |
| 00014081053190 | Plast Frame | HAGER WORLDWIDE, INC. | EJE | 2023-03-27 |
| 07630392900409 | Hysolate | Dent4You AG | EJE | 2023-02-28 |
| 07630392900416 | Hysolate | Dent4You AG | EJE | 2023-02-28 |
| 07630392900423 | Hysolate | Dent4You AG | EJE | 2023-02-28 |
| 07630392900430 | Hysolate | Dent4You AG | EJE | 2023-02-28 |
| 07630392900447 | Hysolate | Dent4You AG | EJE | 2023-02-28 |
| D24835531919 | Plast Frame | HAGER WORLDWIDE, INC. | EJE | 2022-12-05 |
| 07506338300582 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-11-04 |
| 07506338300636 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-11-03 |
| 10302731714018 | Young | YOUNG DENTAL MANUFACTURING I, LLC | EJE | 2022-10-16 |
| 10302731770014 | Young | YOUNG DENTAL MANUFACTURING I, LLC | EJE | 2022-10-16 |
| 10302731771011 | Young | YOUNG DENTAL MANUFACTURING I, LLC | EJE | 2022-10-16 |
| 10302731776016 | Young | YOUNG DENTAL MANUFACTURING I, LLC | EJE | 2022-10-16 |
| 10302731777013 | Young | YOUNG DENTAL MANUFACTURING I, LLC | EJE | 2022-10-16 |
| 07506338300513 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-28 |
| 07506338300520 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-28 |
| 07506338300537 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-28 |
| 07506338300551 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-28 |
| 07506338300605 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-28 |
| 07506338300612 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-28 |
| 07506338300629 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-28 |
| 07506338300643 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-28 |
| 00810060723258 | Adult Rubber Dam Frame - 15 cm | Berman Instruments LLC | EJE | 2022-09-21 |
| 00810060723265 | Child Rubber Dam Frame - 13 cm | Berman Instruments LLC | EJE | 2022-09-21 |
| 07506338300650 | Nic Tone, MDC Dental | MDC DENTAL | EJE | 2022-09-09 |