OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
FDA 510(k) clearance K980159 · decided 1998-04-09
Clearance details
- K-number
- K980159
- Device name
- OCTYLDENT (2-OCTYL CYANOACRYLATE), 02A01
- Applicant
- Closure Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-16
- Decision date
- 1998-04-09
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- EMA
- Device class
- 2
- Regulation number
- 872.3275
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Raleigh, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Closure Medical Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PacTemp Automix NE (K261937) | The Belport Company Inc., DBA Gingi-Pak | 2026-08-07 |
| DIA-CEM (K261166) | DiaDent Group International | 2026-07-09 |
| G-CEM UNIVERSAL (K254109) | GC America, Inc. | 2026-05-18 |
| REGEN Bioactive Cement (K253337) | Inter-Med, Inc. | 2026-04-15 |
| Bifix Veneer LC, Bifix Veneer Try-In (K252606) | Voco GmbH | 2026-03-20 |
| iCEM Universal Plus (K254063) | Kulzer, LLC | 2025-12-19 |
| TopCEM Vigor SA Self-Adhesive Resin Cement (K252785) | Rizhao Huge Biomaterials Company, Ltd. | 2025-12-12 |
| GlasIonomer FX-LC (K252808) | Shofu Dental Corporation | 2025-12-09 |
| ZIRCONOMER P (K252165) | Shofu Dental Corporation | 2025-10-28 |
| EQUIA LC ONE (K250953) | GC America, Inc. | 2025-09-19 |
| RODIN Cement (K251775) | Belport Company, Inc., Gingi-Pak | 2025-09-02 |
| Choice 2 DC (K250156) | Bisco, Inc. | 2025-07-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S012) | Closure Medical Corp. | 2006-09-14 |
| HIGH VISCOSITY DERMABOND MINI APPLICATOR (P960052/S011) | Closure Medical Corp. | 2006-02-10 |
| HIGH VISCOSITY DERMABOND TOPICAL SKIN ADHESIVE (P960052/S010) | Closure Medical Corp. | 2005-03-21 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S009) | Closure Medical Corp. | 2004-09-24 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S007) | Closure Medical Corp. | 2003-12-01 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S006) | Closure Medical Corp. | 2003-06-13 |
| DERMABOND(R) TOPICAL SKIN ADHESIVE/HIGH VISCOSITY (P960052/S004) | Closure Medical Corp. | 2002-12-31 |
| DERMABOND TOPICAL SKIN ADHESIVE (P960052/S005) | Closure Medical Corp. | 2002-07-24 |