Turbo-CR
- Primary DI
- 00766054002994
- Brand
- Turbo-CR
- Company
- ESSENTIAL DENTAL SYSTEMS, INC.
- Model
- 1100-00
- Catalog number
- 1100-00
- Device description
- Calculus Softener
- Published
- 2025-04-04
- Public version status
- New
- Distribution status
- Not in Commercial Distribution
- MRI safety
- Labeling does not contain MRI Safety Information
- Rx
- true
Contact Domains#
edsdental.comProduct Codes#
| Code | Name |
|---|---|
| ELC | Scaler, ultrasonic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K223340 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| 00766054002994 | Primary | GS1 | 0 |
Alternate GTIN / UPC / EAN Codes
| Source identifier | GTIN-14 normalized | UPC-A | EAN-13 |
|---|---|---|---|
| 00766054002994 | 00766054002994 | 766054002994 | 0766054002994 |
GMDN Terms#
| Term | Definition |
|---|---|
| Dental scaling solution | A liquid substance used in dentistry to soften and partially solubilize a dental calculus (a hard deposit that forms on the teeth) before scaling mechanically so that less force is required, especially when teeth are loose. It will typically contain acid as a solvent (e.g., hydrochloric) and include other elements (e.g., iodine and excipients). After application, this device cannot be reused. |
Sterilization Methods#
| Method |
|---|
Contacts#
| Phone | |
|---|---|
| +1(201)487-9090 | udi@edsdental.com |
Regulatory Flags#
- DUNS number
- 101147171
- Device count
- 1
- Lot or batch
- true
- Manufacturing date on label
- true
- Expiration date on label
- true
Other Devices From This Company#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| 00766054002987 | Turbo-CR | 1100-30 | 1100-30 | 2025-04-04 |
| 00766054003007 | Turbo-CR | 1100-100 | 1100-100 | 2025-04-04 |
| 00766054002949 | BIOSEAL | 1640-00 | 1640-00 | 2024-10-31 |
| 00766054002970 | BIOSEAL | 1640-15 | 1640-15 | 2024-10-31 |
| 00766054000341 | EDS Self Etch Bonding Agent | 900-00 | 900-00 | 2017-02-01 |
| 00766054000693 | Tango-Endo | 5300-00 | 5300-00 | 2020-07-17 |
| 00766054001201 | Endo-Express | 5510-00 | 5510-00 | 2020-07-10 |
| 00766054001218 | Endo-Express | 5520-00 | 5520-00 | 2020-07-10 |
| 00766054002710 | Endo CSV | 5100-00 | 5100-00 | 2020-07-17 |
| 00766054002727 | Endo CSV | 5121-00 | 5121-00 | 2020-07-17 |
| 00766054002734 | Endo CSV | 5125-00 | 5125-00 | 2020-07-17 |
| 00766054002840 | Endo CSV | 5100-RH | 5100-RH | 2020-07-17 |
| 00766054000259 | EZ-Fill Bi-Directional Spiral | 1600-21 | 1600-21 | 2020-07-10 |
| 00766054000266 | EZ-Fill Bi-Directional Spiral | 1600-25 | 1600-25 | 2020-07-10 |
| 00766054000273 | EZ-Fill Bi-Directional Spiral | 1600-01 | 1600-01 | 2020-07-10 |
| 00766054000280 | EZ-Fill Bi-Directional Spiral | 1605-21 | 1605-21 | 2020-07-10 |
| 00766054000297 | EZ-Fill Bi-Directional Spiral | 1605-25 | 1605-25 | 2020-07-10 |
| 00766054000303 | EZ-Fill Bi-Directional Spiral | 1605-01 | 1605-01 | 2020-07-10 |
| 00766054001188 | Endo-Express | 5500-00 | 5500-00 | 2020-07-10 |
| 00766054001195 | Endo-Express | 5500TEP | 5500TEP | 2020-07-10 |
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 |