MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
FDA 510(k) clearance K864307 · decided 1986-11-18
Clearance details
- K-number
- K864307
- Device name
- MAX-I-PROBE PERIDONTAL/ENDODONTIC PROBE(TM) (MODI)
- Applicant
- Smith & Nephew, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-11-03
- Decision date
- 1986-11-18
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- EIC
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Chicago, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RCT GEL ROOT CANAL THERAPY GEL (K972234) | Dentsply Intl. | 1997-06-30 |
| HYDRON ROOT CANAL FILLING & MARK IV STARTER KIT (K861846) | Solar Dental Co., Inc. | 1986-06-26 |
| MAX-I-PROBE HANDPIECE (K851944) | Solo Pak Laboratories | 1985-07-01 |
| MAX-I-PROBE PERIODONTAL ENDODONTIC PROB (K840237) | Smith & Nephew, Mpl Division | 1984-04-05 |
| R & S SERIES FITTING TOOLS (K811889) | Suncoast Dental Corp. | 1981-07-24 |
| WATER PISTOL (K811594) | Aus-Tex Dental Mfg. & Design | 1981-07-15 |
| ROOT CANAL FILLING APPLICATOR NEEDLES (K801484) | National Patent Development Corp. | 1980-07-21 |
| MARK IV SYRINGE (K801483) | National Patent Development Corp. | 1980-07-21 |
| EPIC CANNULA (K792578) | Dental Development Services, Inc. | 1980-01-04 |
| ENDOVAGE SYRINGE (K792577) | Dental Development Services, Inc. | 1980-01-04 |
| CENTRIX MKIV ENDODONTIC DELIVERY (K792461) | Centrix, Inc. | 1979-12-19 |
| GUTTA GUN (K771406) | Aus-Tex Dental Mfg. & Design | 1977-08-26 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Ascension MCP (P000057/S013) | Smith & Nephew, Inc. | 2025-12-31 |
| ASCENSION MCP (P000057/S014) | Smith & Nephew, Inc. | 2025-08-05 |
| R3 Delta Ceramic Acetabular System (P150030/S049) | Smith & Nephew, Inc. | 2025-04-17 |
| R3 DELTA CERAMIC HIP SYSTEM (P150030/S048) | Smith & Nephew, Inc. | 2025-03-03 |
| R3 Delta Ceramic Hip System (P150030/S045) | Smith & Nephew, Inc. | 2025-02-28 |
| R3 Delta Ceramic Acetabular System (P150030/S047) | Smith & Nephew, Inc. | 2025-02-21 |
| R3 Delta Ceramic Acetabular System (P150030/S046) | Smith & Nephew, Inc. | 2025-01-16 |
| BIRMINGHAM HIP RESURFACING (BHR) SYSTEM (P040033/S039) | Smith & Nephew, Inc. | 2025-01-10 |