Lynx Scalemaster
- Primary DI
- D826LX3002H040
- Brand
- Lynx Scalemaster
- Company
- MTI Precision Products, LLC
- Model
- LX3002H04
- Device description
- The Lynx Scalemaster in an ultrasonic scaler a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits for teeth by application of a sonic vibrating scaler tip to the teeth.
- Published
- 2016-09-22
- Public version status
- Update
- 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 |
|---|---|
| ELC | Scaler, Ultrasonic |
Product Code Classifications#
| Code | Device | Specialty | Class |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | Dental | 2 |
Premarket Submissions#
| Submission | Supplement |
|---|---|
| K901488 | 000 |
Premarket Details#
Identifiers And Packaging#
| Identifier | Type | Agency | Package quantity | Status |
|---|---|---|---|---|
| D826LX3002H040 | Direct Marking | HIBCC | 0 | |
| D826LX3002H041 | Primary | HIBCC | 0 |
GMDN Terms#
| Term | Definition |
|---|---|
| Rotary dental scaler | An abrasive device intended to be attached to a powered dental handpiece that provides rotation and is used to remove calculus deposits and other accretions from tooth surfaces during dental cleaning and periodontal (gum) therapy. This is a reusable device. |
Sterilization Methods#
| Method |
|---|
| Moist Heat or Steam Sterilization |
Regulatory Flags#
- DUNS number
- 081600128
- Device count
- 1
- DM exempt
- false
- Premarket exempt
- false
- HCT/P
- false
- Kit
- false
- Combination product
- false
- Lot or batch
- false
- Serial number
- true
- 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#
| Primary DI | Brand | Model | Catalog | Published |
|---|---|---|---|---|
| D8265007703 | LYNX MASTER CLASSIC M0TOR | 50077-03 | 2023-02-10 | |
| D8265008703 | LYNX MASTER CLASSIC MOTOR | 50087-03 | 2023-02-10 | |
| D8265013503 | MASTER SWIVEL LYNX CLASSIC MOTOR | 5013503 | 2023-02-10 | |
| D8265013604 | MASTER TORQUEMASTER 5 | 5013604 | 2023-02-10 | |
| D8265015403 | MASTER PROPHY AIRLITE | 50154-03 | 2023-02-10 | |
| D8265015406 | MASTER PROPHY AIRLITE | 50154-06 | 2023-02-10 | |
| D8265015408 | MASTER PROPHY AIRLITE | 50154-08 | 2023-02-10 | |
| D8265016304 | MASTER PRO 5 | 50163-04 | 2023-02-10 | |
| D8265025003 | PROPHY AIRLITE 4-HOLE | 5025003 | 2023-02-10 | |
| D8265025006 | PROPHY AIRLITE 4-HOLE | 5025006 | 2023-02-10 | |
| D8265025008 | PHOPHY AIRLITE 4-HOLE | 5025008 | 2023-02-10 | |
| D826LX100B2 | LYNX CLASSIC MOTOR | LX100B2H | 2023-02-10 | |
| D826LX10104 | LYNX 4:1 REDUCTION CONTRA ANGLE | LX101 | 2023-02-10 | |
| D826LX11SNCL03 | LYNX LONG BLUE NOSECONE | LX11SNCL | 2023-02-10 | |
| D826LX11SNCS03 | LYNX SHORT BLUE NOSECONE | LX11SNCS | 2023-02-10 | |
| D826LX14SNCL04 | LYNX 4:1 REDUCTION NOSECONE | LX14SNCL | 2023-02-10 | |
| D826LXPRO54 | LYNX PRO 5 | LXPRO5-4H | 2023-02-10 | |
| D826LXTM52 | TORQUEMASTER 5 2-HOLE | LXTM52 | 2023-02-10 | |
| D826LXTM54 | TORQUEMASTER 5 4-HOLE | LXTM54 | 2023-02-10 | |
| D826TM202 | TORQUEMASTER 20 2-HOLE | TM202 | 2023-02-10 |
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