Geistlich Bio-Oss Pen (0.25 G, 0.25-1.0Mm Granules), Geistlich Bio-Oss Pen (0.5 G, 0.25-1.0Mm Granules), Geistlich Bio-O
K120601 is the FDA 510(k) clearance record for GEISTLICH BIO-OSS PEN (0.25 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-OSS PEN (0.5 G, 0.25-1.0MM GRANULES), GEISTLICH BIO-O, a class II device, cleared for Geistlich Pharma AG on under FDA product code NPM (Bone Grafting Material, Animal Source). FDA's definition for product code NPM reads: "A animal-source bone grafting material is a naturally-derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw". FDA records list 43 510(k) clearances for Geistlich Pharma AG, from to . As of , FDA records show 6 recalls naming K120601.
Clearance record
- Decision date
- Received
- (86 days to decision)
- Product code
- NPM Bone Grafting Material, Animal Source
- Regulation
- 21 CFR 872.3930
- Device class
- Class II
- Review panel
- Dental
- Applicant
- Geistlich Pharma AG 555 Twelfth St., NW, Washington DC
- 510(k) summary
- Summary PDF
- Third party review
- No
Clearances, product code NPM
Trailing 12 monthsShow the numbers
| Month | Clearances |
|---|---|
| November 2025 | 0 |
| December 2025 | 0 |
| January 2026 | 0 |
| February 2026 | 0 |
| March 2026 | 0 |
| April 2026 | 0 |
| May 2026 | 0 |
| June 2026 | 1 |
| July 2026 | 0 |
| August 2026 | 0 |
| September 2026 | 1 |
| October 2026 | 0 |
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