| Primary Device ID | D961M50040 |
| NIH Device Record Key | 85909877-cb24-4f86-b2ea-d777afcb31bc |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Dowell Dental Products, Inc |
| Version Model Number | M5004 |
| Company DUNS | 004041234 |
| Company Name | Dowell Dental Products, Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com | |
| Phone | 9092973646 |
| support@dowelldentalproducts.com |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | D961M50040 [Primary] |
| EMN | Scaler, Periodontic |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
[D961M50040]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-08-31 |
| Device Publish Date | 2022-08-23 |
| D961S10280 | Sinus Lift Instrument |
| D961MS103904 | Bone Packer Condenser |
| D961MS5010B0 | PRICHARD 1/2 |
| D961MS12890 | SINGLE BLADE HOLDER |
| D961MS12800 | MICRO BLADE HOLDER |
| D961MS12590 | 5 PCS CASSETTE |
| D961MS12330 | MODIFIED TUNELLING |
| D961MS1112S0 | SERRATED CURETTE |
| D961MS10260 | MODIFIED BONE CARRIER |
| D961MS10050 | ORBAN KNIFE |
| D961M50070 | MIRROR HANDLE / MIRROR |
| D961M50060 | GRACY CURETTE |
| D961M50040 | HYGIENE 1 |
| D961MS1010B0 | Surgical Curettes PR1/2, |