IRIS
- Primary DI
- D74437589360
- Brand
- IRIS
- Company
- BENCO DENTAL SUPPLY CO.
- Model
- 3758-936
- Catalog number
- D804
- Device description
- Benco’s 30kHz 110v Iris Ultrasonic Tooth Scaler
- Published
- 2017-02-13
- Public version status
- Update
- Distribution status
- In Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Product Codes#
| Code | Name |
|---|---|
| ELC | Scaler, Ultrasonic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 2 |
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D74437589360 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Ultrasonic dental scaling/debridement system | An assembly of mains electricity (AC-powered) devices intended to apply ultrasonic oscillations to: 1) mechanically fragment and dislodge gross debris in the dental pulp canal during an endodontic procedure; and/or 2) remove accretions from tooth surfaces during dental cleaning/periodontal therapy. The system typically consists of a generator with controls (e.g., foot-switch) that produces and controls high frequency electric current, and may provide fluid irrigation; a handpiece used to convert the energy to ultrasonic oscillations; and a tip(s) intended to apply the oscillations to the procedure site; tip selection typically affects the intended application (endodontic vs periodontal). |
Regulatory Flags#
- DUNS number
- 015108087
- Device count
- 1
- Serial number
- true
- Manufacturing date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00366975013347 | FAS-TRACT | 4006-906 | 2018-12-05 | |
| 00366975001887 | BENCO | 3630-331 | 2016-09-23 | |
| D74451864890 | BENCO | 5186-489 | 2017-11-29 | |
| D74451864980 | BENCO | 5186-498 | 2017-11-29 | |
| D74451865230 | BENCO | 5186-523 | 2017-11-29 | |
| D74451865320 | BENCO | 5186-532 | 2017-11-29 | |
| D74451865410 | BENCO | 5186-541 | 2017-11-29 | |
| 00366975001894 | BENCO | 3630-368 | 2016-09-23 | |
| 00366975001900 | BENCO | 3630-386 | 2016-09-23 | |
| 00366975001917 | BENCO | 3630-402 | 2016-09-23 | |
| 00366975032768 | BENCO | 3630-055 | 2016-09-23 | |
| 00366975070005 | Sterling | 5259-516 | 2025-02-26 | |
| 00366975069993 | Sterling | 6694-642 | 2025-02-26 | |
| 00366975058768 | BENCO | 5726-583 | 2022-08-04 | |
| 00366975003317 | BENCO | 3470-424 | 2016-09-23 | |
| 00366975003409 | BENCO | 3470-415 | 2016-09-23 | |
| D744101162914 | Gibson Healthcare | 1011-629 | 1011-629 | 2015-10-22 |
| D744101164714 | Gibson Healthcare | 1011-647 | 1011-647 | 2015-10-22 |
| D74417597511 | Gibson Healthcare | 1759751 | 1759751 | 2017-02-13 |
| D74419672861 | Gibson Healthcare | 1967-286 | 1967-286 | 2017-02-13 |
Other Devices Sharing Product Codes#
| Primary DI | Brand | Company | Product code | Published |
|---|---|---|---|---|
| 07630392912617 | BioSonic | Dent4You AG | ELC | 2026-04-06 |
| 07630392912624 | BioSonic | Dent4You AG | ELC | 2026-04-06 |
| 07630392912631 | BioSonic | Dent4You AG | ELC | 2026-04-06 |
| 07630392912648 | BioSonic | Dent4You AG | ELC | 2026-04-06 |
| 07613353352356 | GBT Machine AIRFLOW Prophylaxis Master | E.M.S. Electro Medical Systems S.A. | ELC | 2026-02-24 |
| 07613353313500 | GBT Machine Station | E.M.S. Electro Medical Systems S.A. | ELC | 2026-02-16 |
| 10889950154066 | PWR Air | HU-FRIEDY MFG. CO., LLC | ELC | 2026-01-14 |
| 10889950154080 | HuFriedyGroup | HU-FRIEDY MFG. CO., LLC | ELC | 2026-01-14 |
| 10889950154103 | HuFriedyGroup | HU-FRIEDY MFG. CO., LLC | ELC | 2026-01-14 |
| 07613353335113 | PIEZON | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-21 |
| 07613353341404 | Piezon | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-21 |
| 07613353257224 | AIR-FLOW-PIEZON | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-20 |
| 07613353257323 | AIR-FLOW-PIEZON | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-20 |
| 07613353257576 | AIR-FLOW-PIEZON | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-20 |
| 07613353258061 | AIR-FLOW | E.M.S. Electro Medical Systems S.A. | ELC | 2025-10-20 |
| 10810000520630 | Parkell® | PARKELL, INC. | ELC | 2023-10-20 |
| 10810000521552 | Parkell® | PARKELL, INC. | ELC | 2023-10-20 |
| J021303230001 | Proxeo ULTRA PB-510 | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303240001 | Proxeo ULTRA PB-520 | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303250001 | Proxeo ULTRA PB-530 | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303260001 | Proxeo ULTRA Handpiece PB-5 L | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303270001 | Proxeo ULTRA Handpiece PB-5 L Q | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303280001 | Proxeo ULTRA Handpiece PB-5 L S | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303530001 | MC-2.0 I (Motorcontroller Implantology) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303580001 | Perestaltic Pump | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303630001 | EXP-PD-ST-00 (Pump Controller) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303440001 | APP-HC-03-XX-00 (Head Controller) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303470001 | IFB-DC-CO.CO-HS-00 (Interface Board) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021303480001 | RFB-03-0200-00 (Rectifier-Board) | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-19 |
| J021302780001 | MC-1.0 and AD-1.0 Analog Motorcontroller | W & H Dentalwerk Bürmoos GmbH | ELC | 2023-07-11 |